K201493 is an FDA 510(k) clearance for the Spirometer. This device is classified as a Spirometer, Diagnostic (Class II - Special Controls, product code BZG).
Submitted by Mehow Innovative, Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 10, 2021, 371 days after receiving the submission on June 4, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840.
| 510(k) Number | K201493 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2020 |
| Decision Date | June 10, 2021 |
| Days to Decision | 371 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZG - Spirometer, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1840 |