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 Cable, Transducer And Electrode, Patient, (Including Connector)
510(k) Number K984263
Device Name EWC: ECG II CABLE LEADWIRE SYSTEM
Applicant
Ewc
N26w23315 Paul Rd.
Pewaukee,  WI  53072 -4061
Applicant Contact TIM DAVIS
Correspondent
Ewc
N26w23315 Paul Rd.
Pewaukee,  WI  53072 -4061
Correspondent Contact TIM DAVIS
Regulation Number870.2900
Classification Product Code
DSA  
Date Received11/30/1998
Decision Date 02/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-