Cleared Traditional

LUNG DIFFUSION MIXTURE

K954542 · Liquid Technology Corp. · Anesthesiology

Dec 1995

Decision

84d

Days

Class 1

Risk

About This 510(k) Submission

K954542 is an FDA 510(k) clearance for the LUNG DIFFUSION MIXTURE, a Gas, Calibration (specified Concentration) (Class I — General Controls, product code BXK), submitted by Liquid Technology Corp. (Orlando, US). The FDA issued a Cleared decision on December 22, 1995, 84 days after receiving the submission on September 29, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.6400.

Submission Details

510(k) Number	K954542 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 1995
Decision Date	December 22, 1995
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement