QardioCore
Recorder, Magnetic Tape, Medical
Qardio Inc.
The following data is part of a premarket notification filed by Qardio Inc. with the FDA for Qardiocore.
Pre-market Notification Details
| Device ID | K201644 |
| 510k Number | K201644 |
| Device Name: | QardioCore |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | Qardio Inc. 345 California Street, Suite 600 & 700 San Francisco, CA 94104 |
| Contact | Rosario Iannella |
| Correspondent | Rosario Iannella Qardio Inc. 345 California Street, Suite 600 & 700 San Francisco, CA 94104 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-17 |
| Decision Date | 2021-02-28 |
Trademark Results [QardioCore]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QARDIOCORE 86628919 5151832 Live/Registered |
QARDIO, INC. 2015-05-13 |
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