QARDIOARM
System, Measurement, Blood-pressure, Non-invasive
QARDIO, INC.
The following data is part of a premarket notification filed by Qardio, Inc. with the FDA for Qardioarm.
Pre-market Notification Details
| Device ID | K140067 |
| 510k Number | K140067 |
| Device Name: | QARDIOARM |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | QARDIO, INC. 340 S LEMON AVE #1104F Walnut, CA 91789 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min QARDIO, INC. 340 S LEMON AVE #1104F Walnut, CA 91789 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-10 |
| Decision Date | 2014-06-18 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854894005210 | K140067 | 000 |
| 00854894005012 | K140067 | 000 |
| 00854894005029 | K140067 | 000 |
| 00854894005036 | K140067 | 000 |
| 00854894005043 | K140067 | 000 |
| 00854894005050 | K140067 | 000 |
| 00854894005067 | K140067 | 000 |
| 00854894005074 | K140067 | 000 |
| 00854894005081 | K140067 | 000 |
| 00854894005104 | K140067 | 000 |
| 00854894005111 | K140067 | 000 |
| 00854894005135 | K140067 | 000 |
| 00854894005203 | K140067 | 000 |
| 00854894005005 | K140067 | 000 |
Trademark Results [QARDIOARM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QARDIOARM 86629597 4971993 Live/Registered |
QARDIO, INC. 2015-05-14 |
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