Blood Gas Mixture

FDA 510(k) K924795 · Gulf States Airgas

Substantially Equivalent

510(k) numberK924795

Submission

Device name
Blood Gas Mixture
Applicant
Gulf States Airgas
Theodore, AL, US
Received
September 23, 1992
Decision date
December 17, 1992
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
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

More from Tri-Gas, Inc.

510(k)DeviceDecision
K924796Lung Diffusion Gas MixtureBXK · Traditional 12/17/1992SE

Questions and answers

When was Blood Gas Mixture cleared by the FDA?

Blood Gas Mixture (K924795) received a 510(k) decision of Substantially Equivalent on December 17, 1992, 85 days after the submission was received.

What is the product code of K924795?

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