The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Spacelabs Series 600 Patient Monitors.
| Device ID | K844888 |
| 510k Number | K844888 |
| Device Name: | SPACELABS SERIES 600 PATIENT MONITORS |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth, CA 91311 |
| Contact | Allen M Hans |
| Correspondent | Allen M Hans SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth, CA 91311 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-17 |
| Decision Date | 1985-02-01 |