BRONCHODILATOR TEE - 9056 SERIES

Nebulizer (direct Patient Interface)

BOEHRINGER LABORATORIES

The following data is part of a premarket notification filed by Boehringer Laboratories with the FDA for Bronchodilator Tee - 9056 Series.

Pre-market Notification Details

Device IDK873521
510k NumberK873521
Device Name:BRONCHODILATOR TEE - 9056 SERIES
ClassificationNebulizer (direct Patient Interface)
Applicant BOEHRINGER LABORATORIES P.O. BOX 870 Norristown,  PA  19404
ContactJohn R Boehringer
CorrespondentJohn R Boehringer
BOEHRINGER LABORATORIES P.O. BOX 870 Norristown,  PA  19404
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-01
Decision Date1988-03-02

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