K240555 is an FDA 510(k) clearance for the Tyto Insights for Crackles 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 July 2, 2024, 125 days after receiving the submission on February 28, 2024.
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 | K240555 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2024 |
| Decision Date | July 02, 2024 |
| Days to Decision | 125 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. |