Device Classification Name |
Recorder, Magnetic Tape, Medical
|
510(k) Number |
K210179 |
Device Name |
QOCA Portable ECG Monitoring Device |
Applicant |
Quanta Computer Inc. |
No. 188, Wenhua 2nd Road, Guishan District |
Taoyuan City,
TW
33377
|
|
Applicant Contact |
Vivian Yang |
Correspondent |
Quanta Computer Inc. |
No. 188, Wenhua 2nd Road, Guishan District |
Taoyuan City,
TW
33377
|
|
Correspondent Contact |
Vivian Yang |
Regulation Number | 870.2800
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/22/2021 |
Decision Date | 08/02/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|