AIRCARE 300

Generator, Oxygen, Portable

MEDCOM

The following data is part of a premarket notification filed by Medcom with the FDA for Aircare 300.

Pre-market Notification Details

Device IDK830324
510k NumberK830324
Device Name:AIRCARE 300
ClassificationGenerator, Oxygen, Portable
Applicant MEDCOM 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCAW  
CFR Regulation Number868.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-02-01
Decision Date1983-03-10

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