Company ยท US
Telediagnostic Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 2007. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 5, 2007 | K071661 | ALPHAONE BIOFEEDBACK SYSTEM Telediagnostic Systems, Inc. | HCC |
| Dec 31, 2002 | K022249 | NIGHTRON POLYSOMNOGRAPHY SYSTEM Telediagnostic Systems, Inc. | OLV |
| May 16, 1997 | K970659 | DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER Telediagnostic Systems, Inc. | GYE |
| Jun 18, 1991 | K904328 | VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM Telediagnostic Systems, Inc. | GWK |
| Jan 18, 1991 | K904222 | VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER Telediagnostic Systems, Inc. | GWL |
| Mar 22, 1989 | K885328 | RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER Telediagnostic Systems, Inc. | GYE |
| Dec 28, 1988 | K884891 | OC-100 OXIMETER INTERFACE CALIBRATOR Telediagnostic Systems, Inc. | DQA |
| Dec 5, 1988 | K883947 | ISO-100 ISOLATION AMPLIFIER Telediagnostic Systems, Inc. | GYE |
| Dec 11, 1987 | K874257 | S-10 TELEPHONIC POLYSOMNOGRAPH Telediagnostic Systems, Inc. | GYE |
| May 1, 1987 | K871120 | M10 EEG MONITOR SCOPE Telediagnostic Systems, Inc. | GYE |
| May 1, 1981 | K810872 | EEG TELEPHONE RECEIVER MODEL #AFR-J Telediagnostic Systems, Inc. | DXH |
| Nov 26, 1980 | K802656 | MODEL T-6 EEG TELEPHONE TRANSMITTER Telediagnostic Systems, Inc. | GYE |
| Nov 12, 1980 | K802657 | MODEL AFR EEG TELEPHONE RECEIVER Telediagnostic Systems, Inc. | GYE |
| Feb 13, 1978 | K780150 | NEONATAL SCREENING AUDIOMETER Telediagnostic Systems, Inc. | EWO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||