Cleared Traditional

T CLASS HYPERBARIC FACILITIES

K954387 · Reimers Systems, Inc. · Anesthesiology
Dec 1995
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K954387 is an FDA 510(k) clearance for the T CLASS HYPERBARIC FACILITIES, a Chamber, Hyperbaric (Class II — Special Controls, product code CBF), submitted by Reimers Systems, Inc. (Springfield, US). The FDA issued a Cleared decision on December 15, 1995, 118 days after receiving the submission on August 19, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5470.

Submission Details

510(k) Number K954387 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 1995
Decision Date December 15, 1995
Days to Decision 118 days
Submission Type Traditional
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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