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 |