Telediagnostic Systems, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Telediagnostic Systems, Inc.” (first 1978, latest 2007), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 64 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 |
|---|---|---|---|
| GYE | Encephalogram Telemetry System | 7 | 7 |
| DQA | Oximeter | 1 | 1 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 | 1 |
| EWO | Audiometer | 1 | 1 |
| GWK | Conditioner, Signal, Physiological | 1 | 1 |
| GWL | Amplifier, Physiological Signal | 1 | 1 |
| HCC | Device, Biofeedback | 1 | 1 |
| OLV | Standard Polysomnograph With Electroencephalograph | 1 | 1 |
Review panels
- Neurology (11)
- Anesthesiology (1)
- Cardiovascular (1)
- Ear, Nose and Throat (1)
Most recent Telediagnostic Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071661 | ALPHAONE BIOFEEDBACK SYSTEM | HCC | 2007-09-05 | 78 |
| K022249 | NIGHTRON POLYSOMNOGRAPHY SYSTEM | OLV | 2002-12-31 | 172 |
| K970659 | DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER | GYE | 1997-05-16 | 84 |
| K904328 | VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM | GWK | 1991-06-18 | 271 |
| K904222 | VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER | GWL | 1991-01-18 | 127 |
| K885328 | RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER | GYE | 1989-03-22 | 84 |
| K884891 | OC-100 OXIMETER INTERFACE CALIBRATOR | DQA | 1988-12-28 | 36 |
| K883947 | ISO-100 ISOLATION AMPLIFIER | GYE | 1988-12-05 | 77 |
| K874257 | S-10 TELEPHONIC POLYSOMNOGRAPH | GYE | 1987-12-11 | 52 |
| K871120 | M10 EEG MONITOR SCOPE | GYE | 1987-05-01 | 43 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Telediagnostic Systems, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Telediagnostic Systems, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Telediagnostic Systems, Inc.” (first 1978, latest 2007), across 8 product codes in 4 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 Telediagnostic Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Telediagnostic Systems, Inc. is 64 days.
Which FDA product codes appear under Telediagnostic Systems, Inc.?
The most frequent FDA product codes under this applicant name are GYE (Encephalogram Telemetry System, 7); DQA (Oximeter, 1); DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 1).
Next steps
- See all 14 Telediagnostic Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GYE, Telediagnostic Systems, 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.