AERO-MIST NEBULIZER

System, Rebreathing, Radionuclide

CADEMA MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Cadema Medical Products, Inc. with the FDA for Aero-mist Nebulizer.

Pre-market Notification Details

Device IDK881812
510k NumberK881812
Device Name:AERO-MIST NEBULIZER
ClassificationSystem, Rebreathing, Radionuclide
Applicant CADEMA MEDICAL PRODUCTS, INC. P.O. BOX 250 Middletown,  NY  10940
ContactKathleen Bordoni
CorrespondentKathleen Bordoni
CADEMA MEDICAL PRODUCTS, INC. P.O. BOX 250 Middletown,  NY  10940
Product CodeIYT  
CFR Regulation Number892.1390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-04-28
Decision Date1988-07-18

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