The following data is part of a premarket notification filed by Qardio Inc with the FDA for Qardioarm 2.
| Device ID | K220106 |
| 510k Number | K220106 |
| Device Name: | QardioArm 2 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| 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 | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-12 |
| Decision Date | 2022-06-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10854894005354 | K220106 | 000 |
| 10854894005347 | K220106 | 000 |