K202062 is an FDA 510(k) clearance for the wheezo WheezeRate Detector. This device is classified as a Abnormal Breath Sound Device (Class II - Special Controls, product code PHZ).
Submitted by Respiri Limited (Melbourne, AU). The FDA issued a Cleared decision on March 11, 2021, 227 days after receiving the submission on July 27, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1900. The Device Is Intended To Measure Abnormal Breath Sound, Such As Wheeze, Rhonchi, And Whistling..
| 510(k) Number | K202062 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 2020 |
| Decision Date | March 11, 2021 |
| Days to Decision | 227 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | PHZ - Abnormal Breath Sound Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1900 |
| Definition | The Device Is Intended To Measure Abnormal Breath Sound, Such As Wheeze, Rhonchi, And Whistling. |