Cleared Traditional

K951125 - LIFEFORCE CLINICAL HYPERBARIC FACILITY
(FDA 510(k) Clearance)

K951125 · Reimers Systems, Inc. · Anesthesiology

Jun 1995

Decision

81d

Days

Class 2

Risk

K951125 is an FDA 510(k) clearance for the LIFEFORCE CLINICAL HYPERBARIC FACILITY, a Chamber, Hyperbaric (Class II — Special Controls, product code CBF), submitted by Reimers Systems, Inc. (Springfield, US). The FDA issued a Cleared decision on June 2, 1995, 81 days after receiving the submission on March 13, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5470.

Submission Details

510(k) Number	K951125 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 13, 1995
Decision Date	June 02, 1995
Days to Decision	81 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF