K191239 is an FDA 510(k) clearance for the Smart Peak Flow Meter. This device is classified as a Meter, Peak Flow, Spirometry (Class II - Special Controls, product code BZH).
Submitted by Guangzhou Homesun Medical Technology Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on December 6, 2019, 212 days after receiving the submission on May 8, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1860.
| 510(k) Number | K191239 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2019 |
| Decision Date | December 06, 2019 |
| Days to Decision | 212 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 |