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 |