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 |