K894973 is an FDA 510(k) clearance for the RESPITRACE PLUS. This device is classified as a Monitor, Apnea, Facility Use (Class II - Special Controls, product code FLS).
Submitted by Hogan & Hartson (Washington, US). The FDA issued a Cleared decision on October 30, 1989, 84 days after receiving the submission on August 7, 1989.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2377.
| 510(k) Number | K894973 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 1989 |
| Decision Date | October 30, 1989 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | FLS — Monitor, Apnea, Facility Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2377 |