Magnetic Resonance Equipment Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Magnetic Resonance Equipment Corp.” (first 1993, latest 2001), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 259 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 | 0 | — |
| 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 |
|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 2 | 2 |
| DQA | Oximeter | 2 | 2 |
| DSK | Computer, Blood-Pressure | 1 | 1 |
Review panels
- Anesthesiology (4)
- Cardiovascular (1)
Most recent Magnetic Resonance Equipment Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003982 | TEMPERATURE FUNCTION, MODEL 9500 MULTIGAS MONITOR | CCK | 2001-01-26 | 35 |
| K983250 | INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR | DSK | 1999-12-12 | 452 |
| K954120 | MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR | CCK | 1997-04-02 | 579 |
| K924285 | MODEL 3500 MR-COMPATIBLE PULSE OXIMETER | DQA | 1993-05-11 | 259 |
| K924282 | MODEL 320 MR-COMPATIBLE PULSE OXIMETER | DQA | 1993-05-07 | 255 |
Recalls
openFDA lists no recalls under a recalling firm named Magnetic Resonance Equipment Corp..
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.
- Magnetic Research, Inc. (9 510(k)s)
- Magnetic Moments, LLC (1 510(k)s)
- Magnetic Resonance Plus, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Magnetic Resonance Equipment Corp.?
FDA lists 5 510(k) clearances under the applicant name “Magnetic Resonance Equipment Corp.” (first 1993, latest 2001), across 3 product codes in 2 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 Magnetic Resonance Equipment Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Magnetic Resonance Equipment Corp. is 259 days.
Which FDA product codes appear under Magnetic Resonance Equipment Corp.?
The most frequent FDA product codes under this applicant name are CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 2); DQA (Oximeter, 2); DSK (Computer, Blood-Pressure, 1).
Next steps
- See all 5 Magnetic Resonance Equipment Corp. clearances with predicates and recalls
- Run predicate analysis for product code CCK, Magnetic Resonance Equipment Corp.'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.