PATIENT CIRCUIT MANIFOLD

Nebulizer (direct Patient Interface)

BOURNS MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Bourns Medical Systems, Inc. with the FDA for Patient Circuit Manifold.

Pre-market Notification Details

Device IDK781485
510k NumberK781485
Device Name:PATIENT CIRCUIT MANIFOLD
ClassificationNebulizer (direct Patient Interface)
Applicant BOURNS MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-08-28
Decision Date1978-10-16

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