K222525 is an FDA 510(k) clearance for the Alveoair Digital Spirometer. This device is classified as a Spirometer, Diagnostic (Class II - Special Controls, product code BZG).
Submitted by Roundworks Technologies Private Limited (Wakad, Pune, IN). The FDA issued a Cleared decision on August 28, 2023, 371 days after receiving the submission on August 22, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840.
| 510(k) Number | K222525 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2022 |
| Decision Date | August 28, 2023 |
| 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 |