Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Electrocardiograph
510(k) Number K002197
Device Name CARTOUCH
Applicant
Cardionics, Inc.
13723 Dana Ln. E.
Puyallup,  WA  98373
Applicant Contact JEFF MORGAN
Correspondent
Cardionics, Inc.
13723 Dana Ln. E.
Puyallup,  WA  98373
Correspondent Contact JEFF MORGAN
Regulation Number870.2340
Classification Product Code
DPS  
Date Received07/20/2000
Decision Date 12/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-