K232237 is an FDA 510(k) clearance for the Tyto Insights for Wheeze Detection. This device is classified as a Abnormal Breath Sound Device (Class II - Special Controls, product code PHZ).
Submitted by Tyto Care , Ltd. (Netanya, IL). The FDA issued a Cleared decision on December 13, 2023, 138 days after receiving the submission on July 28, 2023.
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 | K232237 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2023 |
| Decision Date | December 13, 2023 |
| Days to Decision | 138 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. |