NEBULIZER/HUMIDIFIER

Humidifier, Respiratory Gas, (direct Patient Interface)

CHEMETRON MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Chemetron Medical Products, Inc. with the FDA for Nebulizer/humidifier.

Pre-market Notification Details

Device IDK781537
510k NumberK781537
Device Name:NEBULIZER/HUMIDIFIER
ClassificationHumidifier, Respiratory Gas, (direct Patient Interface)
Applicant CHEMETRON MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeBTT  
CFR Regulation Number868.5450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-09-01
Decision Date1978-10-10

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