The following data is part of a premarket notification filed by Universal Medical, Inc. with the FDA for Heartrak Smart At/heartrak Smart2.
| Device ID | K033451 |
| 510k Number | K033451 |
| Device Name: | HEARTRAK SMART AT/HEARTRAK SMART2 |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | UNIVERSAL MEDICAL, INC. ONE COMMERCE SQUARE 2005 MARKET STREET, SUITE 2340 Philadelphia, PA 19103 |
| Contact | Douglas M Lurio |
| Correspondent | Douglas M Lurio UNIVERSAL MEDICAL, INC. ONE COMMERCE SQUARE 2005 MARKET STREET, SUITE 2340 Philadelphia, PA 19103 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-30 |
| Decision Date | 2004-02-05 |
| Summary: | summary |