H.E.A.R.T. NEBULIZER

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 H.e.a.r.t. Nebulizer.

Pre-market Notification Details

Device IDK900228
510k NumberK900228
Device Name:H.E.A.R.T. NEBULIZER
ClassificationNebulizer (direct Patient Interface)
Applicant B & B MEDICAL TECHNOLOGIES, INC. 3569 RECYCLE RD., SUITE 16 Rancho Cordova,  CA  95670
ContactW Briggs,iii
CorrespondentW Briggs,iii
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 Received1990-01-17
Decision Date1990-03-16

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