Cleared Special

MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER

K052713 · Sechrist Industries, Inc. · Anesthesiology
Oct 2005
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K052713 is an FDA 510(k) clearance for the MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER, a Chamber, Hyperbaric (Class II — Special Controls, product code CBF), submitted by Sechrist Industries, Inc. (Anaheim, US). The FDA issued a Cleared decision on October 28, 2005, 29 days after receiving the submission on September 29, 2005. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5470.

Submission Details

510(k) Number K052713 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2005
Decision Date October 28, 2005
Days to Decision 29 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBF — Chamber, Hyperbaric
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5470

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