RONDEX MASKS MODELS 9015/9011/901102 MODIFIED

Ventilator, Emergency, Manual (resuscitator)

RONDEX PRODUCTS, INC.

The following data is part of a premarket notification filed by Rondex Products, Inc. with the FDA for Rondex Masks Models 9015/9011/901102 Modified.

Pre-market Notification Details

Device IDK914196
510k NumberK914196
Device Name:RONDEX MASKS MODELS 9015/9011/901102 MODIFIED
ClassificationVentilator, Emergency, Manual (resuscitator)
Applicant RONDEX PRODUCTS, INC. P.O. BOX NO. 1829 Rockford,  IL  61110
ContactGene R Baldwin
CorrespondentGene R Baldwin
RONDEX PRODUCTS, INC. P.O. BOX NO. 1829 Rockford,  IL  61110
Product CodeBTM  
CFR Regulation Number868.5915 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-09-05
Decision Date1991-11-08

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