Cleared Special

SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER

K140559 · Sechrist Industries, Inc. · Anesthesiology
May 2014
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K140559 is an FDA 510(k) clearance for the SECHRIST 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 May 30, 2014, 86 days after receiving the submission on March 5, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5470.

Submission Details

510(k) Number K140559 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2014
Decision Date May 30, 2014
Days to Decision 86 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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