Telediagnostic Systems, Inc.
Redwood City, CA, US
Telediagnostic Systems, Inc. appears in FDA device records in Redwood City, CA. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Telediagnostic Systems, Inc. between 1978 and 2007. The busiest year on record is 1980, with 2. The most recent is 2007, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1980 | 2 |
| 1981 | 1 |
| 1987 | 2 |
| 1988 | 2 |
| 1989 | 1 |
| 1991 | 2 |
| 1997 | 1 |
| 2002 | 1 |
| 2007 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K071661 | ALPHAONE BIOFEEDBACK SYSTEM | HCC | Substantially Equivalent | |
| K022249 | NIGHTRON POLYSOMNOGRAPHY SYSTEM | OLV | Substantially Equivalent | |
| K970659 | DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER | GYE | Substantially Equivalent | |
| K904328 | VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM | GWK | Substantially Equivalent | |
| K904222 | VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER | GWL | Substantially Equivalent | |
| K885328 | RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER | GYE | Substantially Equivalent | |
| K884891 | OC-100 OXIMETER INTERFACE CALIBRATOR | DQA | Substantially Equivalent | |
| K883947 | ISO-100 ISOLATION AMPLIFIER | GYE | Substantially Equivalent | |
| K874257 | S-10 TELEPHONIC POLYSOMNOGRAPH | GYE | Substantially Equivalent | |
| K871120 | M10 EEG MONITOR SCOPE | GYE | Substantially Equivalent | |
| K810872 | EEG TELEPHONE RECEIVER MODEL #AFR-J | DXH | Substantially Equivalent | |
| K802656 | MODEL T-6 EEG TELEPHONE TRANSMITTER | GYE | Substantially Equivalent | |
| K802657 | MODEL AFR EEG TELEPHONE RECEIVER | GYE | Substantially Equivalent | |
| K780150 | NEONATAL SCREENING AUDIOMETER | EWO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain