MINI HEART

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 Mini Heart.

Pre-market Notification Details

Device IDK923690
510k NumberK923690
Device Name:MINI HEART
ClassificationNebulizer (direct Patient Interface)
Applicant B & B MEDICAL TECHNOLOGIES, INC. 3569 RECYCLE RD., SUITE 16 Rancho Cordova,  CA  95670
ContactBriggs Ii
CorrespondentBriggs Ii
B & B MEDICAL TECHNOLOGIES, INC. 3569 RECYCLE RD., SUITE 16 Rancho Cordova,  CA  95670
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-24
Decision Date1992-10-20

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