Device Classification Name |
electrocardiograph
|
510(k) Number |
K210560 |
Device Name |
Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph |
Applicant |
Philips Medical Systems |
Building A2, #718 Lingshi Road, Jingan District |
Shanghai,
CN
200072
|
|
Applicant Contact |
Hong Zhu |
Correspondent |
Philips Medical Systems |
Building A2, #718 Lingshi Road, Jingan District |
Shanghai,
CN
200072
|
|
Correspondent Contact |
Hong Zhu |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 02/25/2021 |
Decision Date | 06/30/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|