Device Classification Name |
Transmitters And Receivers, Physiological Signal, Radiofrequency
|
510(k) Number |
K240251 |
Device Name |
ANNE Chest |
Applicant |
Sibel Health Inc. |
2017 N Mendell |
Unit 2SE |
Chicago,
IL
60614
|
|
Applicant Contact |
Sarah Coughlin |
Correspondent |
Sibel Health Inc. |
2017 N Mendell |
Unit 2SE |
Chicago,
IL
60614
|
|
Correspondent Contact |
Sarah Coughlin |
Regulation Number | 870.2910
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/30/2024 |
Decision Date | 06/03/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|