Cleared Special

PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM

K993220 · Puritan Bennett Corp. · Anesthesiology
Oct 1999
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K993220 is an FDA 510(k) clearance for the PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM, a Unit, Liquid-oxygen, Portable (Class II — Special Controls, product code BYJ), submitted by Puritan Bennett Corp. (St. Charles, US). The FDA issued a Cleared decision on October 22, 1999, 25 days after receiving the submission on September 27, 1999. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5655.

Submission Details

510(k) Number K993220 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 1999
Decision Date October 22, 1999
Days to Decision 25 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BYJ — Unit, Liquid-oxygen, Portable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5655

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