Clinical Blood Gas

FDA 510(k) K935311 · Acetylene Gas Co.

Substantially Equivalent

510(k) numberK935311

Submission

Device name
Clinical Blood Gas
Applicant
Acetylene Gas Co.
St. Louis, MO, US
Received
November 2, 1993
Decision date
December 22, 1993
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
K935309Lung DiffusionBZC · Traditional 09/27/1994SE
K935310Medical Laser MixtureGEX · Traditional 12/23/1993SE

Questions and answers

When was Clinical Blood Gas cleared by the FDA?

Clinical Blood Gas (K935311) received a 510(k) decision of Substantially Equivalent on December 22, 1993, 50 days after the submission was received.

What is the product code of K935311?

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