Lung Diffusion Mixtures

FDA 510(k) K954804 · Mittler Supply, Inc.

Substantially Equivalent

510(k) numberK954804

Submission

Device name
Lung Diffusion Mixtures
Applicant
Mittler Supply, Inc.
South Bend, IN, US
Received
October 19, 1995
Decision date
January 25, 1996
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
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
K953934Med-Tech Lung Diffusion MixtureBXK · Traditional Medical Technical Gases Inc..09/18/1995SE
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
K954803Blood Gas MixturesBXK · Traditional 01/25/1996SE

Questions and answers

When was Lung Diffusion Mixtures cleared by the FDA?

Lung Diffusion Mixtures (K954804) received a 510(k) decision of Substantially Equivalent on January 25, 1996, 98 days after the submission was received.

What is the product code of K954804?

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