K183479 is an FDA 510(k) clearance for the Asthma Monitor AM3. This device is classified as a Spirometer, Diagnostic (Class II - Special Controls, product code BZG).
Submitted by Eresearch Technology (Estenfeld, DE). The FDA issued a Cleared decision on October 3, 2019, 290 days after receiving the submission on December 17, 2018.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840.
| 510(k) Number | K183479 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2018 |
| Decision Date | October 03, 2019 |
| Days to Decision | 290 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZG - Spirometer, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1840 |