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 |