Cleared Traditional

CTC 30, 40, 1 LIQUID OXYGEN LITERS

K860738 · Cryodyne Technologies, Inc. · Anesthesiology
Aug 1986
Decision
160d
Days
Class 2
Risk

About This 510(k) Submission

K860738 is an FDA 510(k) clearance for the CTC 30, 40, 1 LIQUID OXYGEN LITERS, a Unit, Liquid-oxygen, Portable (Class II — Special Controls, product code BYJ), submitted by Cryodyne Technologies, Inc. (Riviera Beach, US). The FDA issued a Cleared decision on August 6, 1986, 160 days after receiving the submission on February 27, 1986. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5655.

Submission Details

510(k) Number K860738 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 1986
Decision Date August 06, 1986
Days to Decision 160 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

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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