North East Monitoring, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “North East Monitoring, Inc.” (first 1995, latest 2014), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 125 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 88 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 5 | 5 |
| DSH | Recorder, Magnetic Tape, Medical | 2 | 2 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| MNR | Ventilatory Effort Recorder | 1 | 1 |
Review panels
- Cardiovascular (8)
- Anesthesiology (1)
- General Hospital (1)
Most recent North East Monitoring, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142424 | DR300 HOLTER MONITOR | MWJ | 2014-11-25 | 88 |
| K081861 | HOLTER LX ANALYSIS | MNR | 2008-12-04 | 156 |
| K070014 | AUTO DETECT FOR TELAHEART DR200/E-A | MWJ | 2007-05-25 | 142 |
| K061293 | TELAHEART DIGITAL RECORDER | MWJ | 2006-08-25 | 108 |
| K041901 | SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER | MWJ | 2004-08-31 | 48 |
| K004007 | DR180+OXY | DSH | 2001-01-25 | 30 |
| K001288 | DR180-II | MWJ | 2000-07-20 | 87 |
| K983576 | DR180-R/OXY | FLL | 1999-03-23 | 161 |
| K960925 | NORTHEAST MONITORING DR180 | DSH | 1996-07-31 | 147 |
| K930564 | HOLTER FOR WINDOWS | DQK | 1995-04-19 | 805 |
Recalls
openFDA lists no recalls under a recalling firm named North East Monitoring, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- North American Instrument Corp. (28 510(k)s)
- North American Sterilization & Packaging Co. (16 510(k)s)
- North American Philips Corp. (15 510(k)s)
- North Pacific Dental, Inc. (11 510(k)s)
- North American Technical Services Corp. (9 510(k)s)
- North American Biologicals, Inc. (6 510(k)s)
- North American Medical Products, Inc. (6 510(k)s)
- North American Science Assoc., Inc. (6 510(k)s)
- North Coast Medi-Tek (6 510(k)s)
- North American Alloys, Inc. (5 510(k)s)
- North American Scientific, Inc. (4 510(k)s)
- North Eos Industries, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under North East Monitoring, Inc.?
FDA lists 10 510(k) clearances under the applicant name “North East Monitoring, Inc.” (first 1995, latest 2014), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by North East Monitoring, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name North East Monitoring, Inc. is 125 days.
Which FDA product codes appear under North East Monitoring, Inc.?
The most frequent FDA product codes under this applicant name are MWJ (Electrocardiograph, Ambulatory (Without Analysis), 5); DSH (Recorder, Magnetic Tape, Medical, 2); DQK (Computer, Diagnostic, Programmable, 1).
Next steps
- See all 10 North East Monitoring, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MWJ, North East Monitoring, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.