Cleared Traditional

MODEL DELTA, OM OXYGEN CONCENTRATOR

K952268 · Caire, Inc. · Anesthesiology
Aug 1995
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K952268 is an FDA 510(k) clearance for the MODEL DELTA, OM OXYGEN CONCENTRATOR, a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Caire, Inc. (Littleton, US). The FDA issued a Cleared decision on August 11, 1995, 88 days after receiving the submission on May 15, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K952268 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 1995
Decision Date August 11, 1995
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

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

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