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 Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
510(k) Number K862953
Device Name CLASSIC RESTING SILVER-SILVERCHLORIDE ELECTRODE
Applicant
Classic Medical Products, Inc.
S82 W 19246 Apollo Dr.
Muskego,  WI  53150
Applicant Contact ROBERT A MACUR
Correspondent
Classic Medical Products, Inc.
S82 W 19246 Apollo Dr.
Muskego,  WI  53150
Correspondent Contact ROBERT A MACUR
Regulation Number870.4330
Classification Product Code
DRY  
Date Received08/05/1986
Decision Date 08/25/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-