The following data is part of a premarket notification filed by Medtechs, Llc with the FDA for Qhrv 1 - Health Assessment System.
| Device ID | K080884 |
| 510k Number | K080884 |
| Device Name: | QHRV 1 - HEALTH ASSESSMENT SYSTEM |
| Classification | Electrocardiograph |
| Applicant | MEDTECHS, LLC 111 BEAVER DAM RUN Durhan, NC 27703 |
| Contact | Meghan Ath |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-03-31 |
| Decision Date | 2008-04-11 |
| Summary: | summary |