Cleared Traditional

OXYGEN CONCENTRATOR

K844328 · Hospitak, Inc. · Anesthesiology
Dec 1984
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K844328 is an FDA 510(k) clearance for the OXYGEN CONCENTRATOR, a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Hospitak, Inc. (Lindenhurst, US). The FDA issued a Cleared decision on December 4, 1984, 27 days after receiving the submission on November 7, 1984. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K844328 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 1984
Decision Date December 04, 1984
Days to Decision 27 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CAW — Generator, Oxygen, Portable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5440

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