The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Spacelabs Medical Workstation.
| Device ID | K860834 |
| 510k Number | K860834 |
| Device Name: | SPACELABS MEDICAL WORKSTATION |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond, WA 98073 -9713 |
| Contact | Allen M Hans |
| Correspondent | Allen M Hans SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond, WA 98073 -9713 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-05 |
| Decision Date | 1986-04-29 |