Cleared Abbreviated

RSI 4200

K102831 · Reimers Systems, Inc. · Anesthesiology
Aug 2011
Decision
324d
Days
Class 2
Risk

About This 510(k) Submission

K102831 is an FDA 510(k) clearance for the RSI 4200, a Chamber, Hyperbaric (Class II — Special Controls, product code CBF), submitted by Reimers Systems, Inc. (Lorton, US). The FDA issued a Cleared decision on August 19, 2011, 324 days after receiving the submission on September 29, 2010. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5470.

Submission Details

510(k) Number K102831 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2010
Decision Date August 19, 2011
Days to Decision 324 days
Submission Type Abbreviated
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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