SIDESTREAM DRUG NEBULIZER

Nebulizer (direct Patient Interface)

MEDIC-AID LTD.

The following data is part of a premarket notification filed by Medic-aid Ltd. with the FDA for Sidestream Drug Nebulizer.

Pre-market Notification Details

Device IDK914152
510k NumberK914152
Device Name:SIDESTREAM DRUG NEBULIZER
ClassificationNebulizer (direct Patient Interface)
Applicant MEDIC-AID LTD. HOOK LANE, PAGHAM, Sussex, U.k. Po21 3pp,  GB
ContactM. R Pollington
CorrespondentM. R Pollington
MEDIC-AID LTD. HOOK LANE, PAGHAM, Sussex, U.k. Po21 3pp,  GB
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-09-16
Decision Date1992-05-05

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