Device Classification Name |
detector and alarm, arrhythmia
|
510(k) Number |
K153473 |
Device Name |
Braemar Telemetry Patch System |
Applicant |
Braemar Manufacturing, LLC |
3890 Murphy Canyon Road, Suite 100 |
San Diego,
CA
92123
|
|
Applicant Contact |
Kent Sayler |
Correspondent |
Braemar Manufacturing, LLC |
3890 Murphy Canyon Road, Suite 100 |
San Diego,
CA
92123
|
|
Correspondent Contact |
Kent Sayler |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 12/02/2015 |
Decision Date | 07/22/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|