K221614 is an FDA 510(k) clearance for the TytoCare Lung Sounds Analyzer. 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 February 24, 2023, 266 days after receiving the submission on June 3, 2022.
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 | K221614 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 2022 |
| Decision Date | February 24, 2023 |
| Days to Decision | 266 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. |