Clinical Blood Gas Mixture

FDA 510(k) K942866 · Nordan Smith Welding Supplies

Substantially Equivalent

510(k) numberK942866

Submission

Device name
Clinical Blood Gas Mixture
Applicant
Nordan Smith Welding Supplies
Hattiesburg, MS, US
Received
June 17, 1994
Decision date
September 1, 1994
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
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
K942864Lung DiffusionBZC · Traditional 03/03/1995SE
K942865Laser Gas MixtureGEX · Traditional 08/23/1994SE

Questions and answers

When was Clinical Blood Gas Mixture cleared by the FDA?

Clinical Blood Gas Mixture (K942866) received a 510(k) decision of Substantially Equivalent on September 1, 1994, 76 days after the submission was received.

What is the product code of K942866?

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