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 electrode, electrocardiograph
510(k) Number K982470
Device Name ECG ELECTRODES APRON
Applicant
TAPUZ MEDICAL TECHNOLOGY LTD.
117 AHUZAH ST.
RA'ANANNA,  IL 43373
Applicant Contact SHOSHANA FRIEDMAN
Correspondent
TAPUZ MEDICAL TECHNOLOGY LTD.
117 AHUZAH ST.
RA'ANANNA,  IL 43373
Correspondent Contact SHOSHANA FRIEDMAN
Regulation Number870.2360
Classification Product Code
DRX  
Date Received07/16/1998
Decision Date 10/14/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-