AEROSOL DELIVERY SYSTEM (AERO-TECH II)

Nebulizer (direct Patient Interface)

CADEMA MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Cadema Medical Products, Inc. with the FDA for Aerosol Delivery System (aero-tech Ii).

Pre-market Notification Details

Device IDK873930
510k NumberK873930
Device Name:AEROSOL DELIVERY SYSTEM (AERO-TECH II)
ClassificationNebulizer (direct Patient Interface)
Applicant CADEMA MEDICAL PRODUCTS, INC. P.O. BOX 250 Middletown,  NY  10940
ContactKathleen D Bordoni
CorrespondentKathleen D Bordoni
CADEMA MEDICAL PRODUCTS, INC. P.O. BOX 250 Middletown,  NY  10940
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-25
Decision Date1987-12-07

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