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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K942671
Device Name CPR 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 Received06/06/1994
Decision Date 02/07/1995
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
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