Device Classification Name |
Abnormal Breath Sound Device
|
510(k) Number |
K221614 |
Device Name |
TytoCare Lung Sounds Analyzer |
Applicant |
Tyto Care Ltd. |
14 Beni Gaon Street |
Netanya,
IL
4250803
|
|
Applicant Contact |
Stella Raizelman Perry |
Correspondent |
Tyto Care Ltd. |
14 Beni Gaon Street |
Netanya,
IL
4250803
|
|
Correspondent Contact |
Stella Raizelman Perry |
Regulation Number | 868.1900
|
Classification Product Code |
|
Date Received | 06/03/2022 |
Decision Date | 02/24/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|