The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Spacelabs Medical Patient Monitor.
| Device ID | K930095 |
| 510k Number | K930095 |
| Device Name: | SPACELABS MEDICAL PATIENT MONITOR |
| 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 | 1993-01-08 |
| Decision Date | 1993-09-03 |