The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Spacelabs' System Autorecorder.
| Device ID | K811540 |
| 510k Number | K811540 |
| Device Name: | SPACELABS' SYSTEM AUTORECORDER |
| Classification | Recorder, Paper Chart |
| Applicant | SPACELABS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DSF |
| CFR Regulation Number | 870.2810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-01 |
| Decision Date | 1981-08-13 |