The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Model 90478 & 90479 Telemetry Rec. Module&housing.
| Device ID | K925510 |
| 510k Number | K925510 |
| Device Name: | MODEL 90478 & 90479 TELEMETRY REC. MODULE&HOUSING |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | SPACELABS MEDICAL, INC. 925 SHERMAN AVE. Hamden, CT 06514 |
| Contact | Raymond W Gifford |
| Correspondent | Raymond W Gifford SPACELABS MEDICAL, INC. 925 SHERMAN AVE. Hamden, CT 06514 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-30 |
| Decision Date | 1994-10-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841522108365 | K925510 | 000 |