Cleared Traditional

MODEL 2500E/2500ER HYPERBARIC CHAMBER

K934164 · Sechrist Industries, Inc. · Anesthesiology
Jun 1995
Decision
655d
Days
Class 2
Risk

About This 510(k) Submission

K934164 is an FDA 510(k) clearance for the MODEL 2500E/2500ER 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, 655 days after receiving the submission on August 27, 1993. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5470.

Submission Details

510(k) Number K934164 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 1993
Decision Date June 13, 1995
Days to Decision 655 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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