Cleared Traditional

MODEL 3200P/3200PR HYPERBARIC CHAMBER

K950386 · Sechrist Industries, Inc. · Anesthesiology
Jun 1995
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K950386 is an FDA 510(k) clearance for the MODEL 3200P/3200PR HYPERBARIC 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 June 13, 1995, 132 days after receiving the submission on February 1, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5470.

Submission Details

510(k) Number K950386 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 1995
Decision Date June 13, 1995
Days to Decision 132 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

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

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