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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 K921002
Device Name RONDEX MASK MODELS 9122/9111/9102/911102, 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 Received02/25/1992
Decision Date 10/06/1992
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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