Cleared Special

MODIFICATION TO: SPIRIT

K080023 · Caire, Inc. · Anesthesiology
Jun 2008
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K080023 is an FDA 510(k) clearance for the MODIFICATION TO: SPIRIT, a Unit, Liquid-oxygen, Portable (Class II — Special Controls, product code BYJ), submitted by Caire, Inc. (Marietta, US). The FDA issued a Cleared decision on June 16, 2008, 164 days after receiving the submission on January 4, 2008. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5655.

Submission Details

510(k) Number K080023 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 2008
Decision Date June 16, 2008
Days to Decision 164 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BYJ — Unit, Liquid-oxygen, Portable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5655

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