The following data is part of a premarket notification filed by Universal Medical, Inc. with the FDA for Heartrak Af.
| Device ID | K071130 |
| 510k Number | K071130 |
| Device Name: | HEARTRAK AF |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | UNIVERSAL MEDICAL, INC. 275 PHILLIPS BLVD. Ewing, NJ 08618 |
| Contact | Steven Adamsky |
| Correspondent | Steven Adamsky UNIVERSAL MEDICAL, INC. 275 PHILLIPS BLVD. Ewing, NJ 08618 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-23 |
| Decision Date | 2008-05-14 |
| Summary: | summary |