KardioScreen
Electrocardiograph
IMedrix Inc. (formerly Piitech Inc.)
The following data is part of a premarket notification filed by Imedrix Inc. (formerly Piitech Inc.) with the FDA for Kardioscreen.
Pre-market Notification Details
| Device ID | K191692 |
| 510k Number | K191692 |
| Device Name: | KardioScreen |
| Classification | Electrocardiograph |
| Applicant | iMedrix Inc. (formerly Piitech Inc.) 1525 McCarthy Blvd., Suite 1059 Milpitas, CA 95035 |
| Contact | Srikanth Jadcherla |
| Correspondent | Srikanth Jadcherla iMedrix Inc. (formerly Piitech Inc.) 1525 McCarthy Blvd., Suite 1059 Milpitas, CA 95035 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-25 |
| Decision Date | 2020-01-10 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003374917 | K191692 | 000 |
Trademark Results [KardioScreen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KARDIOSCREEN 88655685 not registered Live/Pending |
Imedrix, Inc. 2019-10-15 |
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