Device Classification Name |
monitor, cardiac (incl. cardiotachometer & rate alarm)
|
510(k) Number |
K181165 |
Device Name |
Philips wearable biosensor-G5 Solution |
Applicant |
Connected Sensing- A Division of Philips Medical Systems |
2 Canal Park |
Cambridge,
MA
02141
|
|
Applicant Contact |
Katie Pacheco |
Correspondent |
Connected Sensing- A Division of Philips Medical Systems |
2 Canal Park |
Cambridge,
MA
02141
|
|
Correspondent Contact |
Katie Pacheco |
Regulation Number | 870.2300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/02/2018 |
Decision Date | 03/07/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|