The following data is part of a premarket notification filed by Narco Air-shields with the FDA for System V.heart Rate/respir. Rate Monit..
| Device ID | K820114 |
| 510k Number | K820114 |
| Device Name: | SYSTEM V.HEART RATE/RESPIR. RATE MONIT. |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | NARCO AIR-SHIELDS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-15 |
| Decision Date | 1982-02-12 |