Cleared Special

PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI

K993088 · Puritan Bennett Corp. · Anesthesiology
Oct 1999
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K993088 is an FDA 510(k) clearance for the PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI, a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Puritan Bennett Corp. (Carlsbad, US). The FDA issued a Cleared decision on October 8, 1999, 22 days after receiving the submission on September 16, 1999. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K993088 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 1999
Decision Date October 08, 1999
Days to Decision 22 days
Submission Type Special
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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