The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Spacelabs Alpha Pc Patient Computer.
| Device ID | K842616 |
| 510k Number | K842616 |
| Device Name: | SPACELABS ALPHA PC PATIENT COMPUTER |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth, CA 91311 |
| Contact | William M Frank |
| Correspondent | William M Frank SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth, CA 91311 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-05 |
| Decision Date | 1984-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841522108761 | K842616 | 000 |
| 10841522100208 | K842616 | 000 |
| 10841522100260 | K842616 | 000 |