The following data is part of a premarket notification filed by Qt Medical, Inc. with the FDA for Qt Ecg.
| Device ID | K180157 |
| 510k Number | K180157 |
| Device Name: | QT ECG |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | QT Medical, Inc. 1001 W Carson Street Suite U Torrance, CA 90502 |
| Contact | Ruey-kang Chang |
| Correspondent | Ruey-kang Chang QT Medical, Inc. 1001 W Carson Street Suite U Torrance, CA 90502 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-19 |
| Decision Date | 2018-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719872980070 | K180157 | 000 |
| 04719872980421 | K180157 | 000 |
| 04719872980414 | K180157 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() QT ECG 98242761 not registered Live/Pending |
QT Medical, Inc. 2023-10-26 |
![]() QT ECG 87518265 5326318 Live/Registered |
QT Medical, Inc 2017-07-06 |
![]() QT ECG 86776634 not registered Dead/Abandoned |
QT Medical, Inc 2015-10-02 |