Cleared Traditional

CALIBRATION GAS

K932520 · Cryodyne Technologies, Inc. · Anesthesiology
Aug 1993
Decision
86d
Days
Class 1
Risk

About This 510(k) Submission

K932520 is an FDA 510(k) clearance for the CALIBRATION GAS, a Gas, Calibration (specified Concentration) (Class I — General Controls, product code BXK), submitted by Cryodyne Technologies, Inc. (Chester, US). The FDA issued a Cleared decision on August 19, 1993, 86 days after receiving the submission on May 25, 1993. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.6400.

Submission Details

510(k) Number K932520 FDA.gov
FDA Decision Cleared SESE
Date Received May 25, 1993
Decision Date August 19, 1993
Days to Decision 86 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BXK — Gas, Calibration (specified Concentration)
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.6400

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