K201002 is an FDA 510(k) clearance for the Safey Pocket Spirometer. This device is classified as a Spirometer, Diagnostic (Class II - Special Controls, product code BZG).
Submitted by Safey Medical Devices Pvt, Ltd. (Pune, IN). The FDA issued a Cleared decision on July 30, 2020, 105 days after receiving the submission on April 16, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840.
| 510(k) Number | K201002 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2020 |
| Decision Date | July 30, 2020 |
| Days to Decision | 105 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 |