The following data is part of a premarket notification filed by Qt Medical, Inc. with the FDA for Pca-c1 Series Patient Cable.
| Device ID | K200722 |
| 510k Number | K200722 |
| Device Name: | PCA-C1 Series Patient Cable |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | QT Medical, Inc. 1360 Valley Vista Dr., Suite 203 Diamond Bar, CA 91765 |
| Contact | Ruey-kang Chang |
| Correspondent | Ruey-kang Chang QT Medical, Inc. 1360 Valley Vista Dr., Suite 203 Diamond Bar, CA 91765 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-19 |
| Decision Date | 2021-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719872980254 | K200722 | 000 |
| 04719872980940 | K200722 | 000 |