MINI O2

K812513 · Mountain Medical Equipment, Inc. · CAW · Sep 21, 1981 · Anesthesiology

Device Facts

Record IDK812513
Device NameMINI O2
ApplicantMountain Medical Equipment, Inc.
Product CodeCAW · Anesthesiology
Decision DateSep 21, 1981
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 868.5440
Device ClassClass 2

Regulatory Classification

Identification

A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).

Innolitics

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