Cleared Traditional

MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURES

K953208 · Standard Welders Supply Co. · Anesthesiology

Jul 1995

Decision

31d

Days

Class 1

Risk

About This 510(k) Submission

K953208 is an FDA 510(k) clearance for the MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURES, a Gas, Calibration (specified Concentration) (Class I — General Controls, product code BXK), submitted by Standard Welders Supply Co. (Memphis, US). The FDA issued a Cleared decision on July 20, 1995, 31 days after receiving the submission on June 19, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.6400.

Submission Details

510(k) Number	K953208 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 19, 1995
Decision Date	July 20, 1995
Days to Decision	31 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement