Device Classification Name |
Electrocardiograph
|
510(k) Number |
K191738 |
Device Name |
PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter 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 | 06/28/2019 |
Decision Date | 09/29/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|