The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Healthepod.
Device ID | K083174 |
510k Number | K083174 |
Device Name: | HEALTHEPOD |
Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
Applicant | CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST., SCIENCE PARK Rehovot, IL 76100 |
Contact | Alex Gonorovsky |
Correspondent | Alex Gonorovsky CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST., SCIENCE PARK Rehovot, IL 76100 |
Product Code | DXH |
CFR Regulation Number | 870.2920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-10-27 |
Decision Date | 2009-12-17 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HEALTHEPOD 78705087 3779546 Dead/Cancelled |
LIFEWATCH AG 2005-09-01 |