Cleared Traditional

SPIRIT 300

K013251 · Caire, Inc. · Anesthesiology
Dec 2001
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K013251 is an FDA 510(k) clearance for the SPIRIT 300, a Unit, Liquid-oxygen, Portable (Class II — Special Controls, product code BYJ), submitted by Caire, Inc. (Burnsville, US). The FDA issued a Cleared decision on December 18, 2001, 81 days after receiving the submission on September 28, 2001. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5655.

Submission Details

510(k) Number K013251 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2001
Decision Date December 18, 2001
Days to Decision 81 days
Submission Type Traditional
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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