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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Manual (Resuscitator)
510(k) Number K914196
Device Name RONDEX MASKS MODELS 9015/9011/901102 MODIFIED
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 Number868.5915
Classification Product Code
BTM  
Date Received09/05/1991
Decision Date 11/08/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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