The following data is part of a premarket notification filed by Cardionics, Inc. with the FDA for Cartouch.
Device ID | K002197 |
510k Number | K002197 |
Device Name: | CARTOUCH |
Classification | Electrocardiograph |
Applicant | CARDIONICS, INC. 13723 DANA LN. EAST Puyallup, WA 98373 |
Contact | Jeff Morgan |
Correspondent | Jeff Morgan CARDIONICS, INC. 13723 DANA LN. EAST Puyallup, WA 98373 |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-07-20 |
Decision Date | 2000-12-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CARTOUCH 97006334 not registered Live/Pending |
CRT BIOTECH LLC 2021-09-01 |
CARTOUCH 76107606 not registered Dead/Abandoned |
Tadiran Telematics Ltd. 2000-08-11 |