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 Valve, Non-Rebreathing
510(k) Number K981169
Device Name RONDEX CPR ISO-SHIELD
Applicant
Rondex Products, Inc.
P.O. Box # 1829
Rockford,  IL  61110
Applicant Contact GENE R BALDWIN
Correspondent
Rondex Products, Inc.
P.O. Box # 1829
Rockford,  IL  61110
Correspondent Contact GENE R BALDWIN
Regulation Number868.5870
Classification Product Code
CBP  
Date Received03/30/1998
Decision Date 05/19/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-