OXY-OFF(TM)

Flowmeter, Calibration, Gas

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 Oxy-off(tm).

Pre-market Notification Details

Device IDK863510
510k NumberK863510
Device Name:OXY-OFF(TM)
ClassificationFlowmeter, Calibration, Gas
Applicant B & B MEDICAL TECHNOLOGIES, INC. P.O. BOX 1503 Orangevale,  CA  95662
ContactBriggs, Iii
CorrespondentBriggs, Iii
B & B MEDICAL TECHNOLOGIES, INC. P.O. BOX 1503 Orangevale,  CA  95662
Product CodeBXY  
CFR Regulation Number868.2350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-09-09
Decision Date1986-10-22

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