The following data is part of a premarket notification filed by Air-shields, Inc. with the FDA for Monitoring System As100-as115 Record.
| Device ID | K832754 |
| 510k Number | K832754 |
| Device Name: | MONITORING SYSTEM AS100-AS115 RECORD |
| Classification | Recorder, Paper Chart |
| Applicant | AIR-SHIELDS, 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 | 1983-08-16 |
| Decision Date | 1983-12-22 |