K914219 is an FDA 510(k) clearance for the AIRWAY THERMISTOR. This device is classified as a Spirometer, Diagnostic (Class II - Special Controls, product code BZG).
Submitted by Synectics-Dantec (Irving, US). The FDA issued a Cleared decision on February 26, 1992, 160 days after receiving the submission on September 19, 1991.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840.
| 510(k) Number | K914219 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 1991 |
| Decision Date | February 26, 1992 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BZG — Spirometer, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1840 |