K843681 is an FDA 510(k) clearance for the RESPIRATION & HEART RATE MONITOR 530. This device is classified as a Monitor, Breathing Frequency (Class II - Special Controls, product code BZQ).
Submitted by Tri-Med, Inc. (Redmond, US). The FDA issued a Cleared decision on December 4, 1984, 77 days after receiving the submission on September 18, 1984.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K843681 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 1984 |
| Decision Date | December 04, 1984 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BZQ — Monitor, Breathing Frequency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2375 |