Device Classification Name |
transmitters and receivers, electrocardiograph, telephone
|
510(k) Number |
K220795 |
Device Name |
QT ECG |
Applicant |
QT Medical, Inc. |
1360 Valley Vista Drive, Suite 203 |
Diamond Bar,
CA
91765
|
|
Applicant Contact |
Jackal Chen |
Correspondent |
QT Medical, Inc. |
1360 Valley Vista Drive, Suite 203 |
Diamond Bar,
CA
91765
|
|
Correspondent Contact |
Jackal Chen |
Regulation Number | 870.2920
|
Classification Product Code |
|
Date Received | 03/18/2022 |
Decision Date | 09/26/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|