Med-Tech Lung Diffusion Mixture

FDA 510(k) K953934 · Medical Technical Gases Inc..

Substantially Equivalent

510(k) numberK953934

Submission

Device name
Med-Tech Lung Diffusion Mixture
Applicant
Medical Technical Gases Inc..
Medford, MA, US
Received
August 18, 1995
Decision date
September 18, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
BXK – Gas, Calibration (Specified Concentration)
Device class
Class I (low risk)
Regulation
21 CFR 868.6400
Specialty
Anesthesiology

Other 510(k)s with product code BXK

510(k)DeviceApplicantDecision
K954804Lung Diffusion MixturesBXK · Traditional Mittler Supply, Inc.01/25/1996SE
K954803Blood Gas MixturesBXK · Traditional Mittler Supply, Inc.01/25/1996SE
K954542Lung Diffusion MixtureBXK · Traditional Liquid Technology Corp.12/22/1995SE
K952838Medical Mixture-Lung Diffusion Gas MixturesBXK · Traditional Standard Welders Supply Co.09/19/1995SE
K953208Medical Mixture-Clinical Blood Gas MixturesBXK · Traditional Standard Welders Supply Co.07/20/1995SE
K944998Calibration GasBXK · Traditional Sunox, Inc.02/03/1995SE
K944812Clinical Blood Gas MixtureBXK · Traditional Laboratory & Specialty Gases, Inc.02/01/1995SE
K942866Clinical Blood Gas MixtureBXK · Traditional Nordan Smith Welding Supplies09/01/1994SE
K932874Blood Gas MixtureBXK · Traditional Tri-Gas, Inc.01/27/1994SE
K935311Clinical Blood GasBXK · Traditional Acetylene Gas Co.12/22/1993SE

More from Acetylene Gas Co.

510(k)DeviceDecision
K953935Med-Tech Clinical Blood GasCHL · Traditional 11/20/1995SE
K953933Med-Tech Laser Gas MixtureGEX · Traditional 09/01/1995SE

Questions and answers

When was Med-Tech Lung Diffusion Mixture cleared by the FDA?

Med-Tech Lung Diffusion Mixture (K953934) received a 510(k) decision of Substantially Equivalent on September 18, 1995, 31 days after the submission was received.

What is the product code of K953934?

The FDA product code is BXK – Gas, Calibration (Specified Concentration), a Class I (low risk) device regulated under 21 CFR 868.6400.