Device Classification Name |
recorder, magnetic tape, medical
|
510(k) Number |
K171936 |
Device Name |
Peerbridge Cor(TM) System |
Applicant |
Peerbridge Health INc. |
1440 Broadway, 23rd Floor |
new york,
NY
10018
|
|
Applicant Contact |
arthur a. bertolero |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
saint paul,
MN
55114
|
|
Correspondent Contact |
mark job |
Regulation Number | 870.2800
|
Classification Product Code |
|
Date Received | 06/28/2017 |
Decision Date | 09/27/2017 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|