K913749 is an FDA 510(k) clearance for the EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170. This device is classified as a Monitor, Breathing Frequency (Class II - Special Controls, product code BZQ).
Submitted by Edentec Corp. (Eden Prairie, US). The FDA issued a Cleared decision on July 2, 1992, 316 days after receiving the submission on August 21, 1991.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K913749 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 1991 |
| Decision Date | July 02, 1992 |
| Days to Decision | 316 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BZQ — Monitor, Breathing Frequency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2375 |