K222810 is an FDA 510(k) clearance for the TD-7301 Peak Flow meter. This device is classified as a Meter, Peak Flow, Spirometry (Class II - Special Controls, product code BZH).
Submitted by Gostar Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on December 19, 2023, 459 days after receiving the submission on September 16, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1860.
| 510(k) Number | K222810 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2022 |
| Decision Date | December 19, 2023 |
| Days to Decision | 459 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZH - Meter, Peak Flow, Spirometry |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1860 |