Cleared Traditional

MED-TECH LUNG DIFFUSION MIXTURE

K953934 · Medical Technical Gases Inc.. · Anesthesiology

Sep 1995

Decision

31d

Days

Class 1

Risk

About This 510(k) Submission

K953934 is an FDA 510(k) clearance for the MED-TECH LUNG DIFFUSION MIXTURE, a Gas, Calibration (specified Concentration) (Class I — General Controls, product code BXK), submitted by Medical Technical Gases Inc.. (Medford, US). The FDA issued a Cleared decision on September 18, 1995, 31 days after receiving the submission on August 18, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.6400.

Submission Details

510(k) Number	K953934 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 18, 1995
Decision Date	September 18, 1995
Days to Decision	31 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement