HEART NEBULIZER FLOWMETER ADAPTOR

Nebulizer (direct Patient Interface)

B & B MEDICAL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by B & B Medical Technologies, Inc. with the FDA for Heart Nebulizer Flowmeter Adaptor.

Pre-market Notification Details

Device IDK913015
510k NumberK913015
Device Name:HEART NEBULIZER FLOWMETER ADAPTOR
ClassificationNebulizer (direct Patient Interface)
Applicant B & B MEDICAL TECHNOLOGIES, INC. P.O. BOX 1503 Orangevale,  CA  95662
ContactStephen W Briggs
CorrespondentStephen W Briggs
B & B MEDICAL TECHNOLOGIES, INC. P.O. BOX 1503 Orangevale,  CA  95662
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-08
Decision Date1991-11-20

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