Device Classification Name |
Transmitters And Receivers, Physiological Signal, Radiofrequency
|
510(k) Number |
K192875 |
Device Name |
Philips Biosensor BX100 |
Applicant |
Philips Medical Systems |
2 Canal Park |
Cambridge,
MA
02141
|
|
Applicant Contact |
Suzanne Goodman |
Correspondent |
Philips Medical Systems |
2 Canal Park |
Cambridge,
MA
02141
|
|
Correspondent Contact |
Suzanne Goodman |
Regulation Number | 870.2910
|
Classification Product Code |
|
Date Received | 10/08/2019 |
Decision Date | 04/16/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|