Calibration Gas

FDA 510(k) K932520 · Cryodyne Technologies, Inc.

Substantially Equivalent

510(k) numberK932520

Submission

Device name
Calibration Gas
Applicant
Cryodyne Technologies, Inc.
Chester, CT, US
Received
May 25, 1993
Decision date
August 19, 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
K926464L.C.S.3000GEH · Traditional 08/24/1993SE
K881465Cryobiological FreezerKSP · Traditional 04/21/1988SE
K881467Microscope Stage HeaterKEJ · Traditional 04/18/1988SE
K881466Cell-Culture ShakerKJB · Traditional 04/18/1988SE
K860738CTC 30, 40, 1 Liquid Oxygen LitersBYJ · Traditional 08/06/1986SE

Questions and answers

When was Calibration Gas cleared by the FDA?

Calibration Gas (K932520) received a 510(k) decision of Substantially Equivalent on August 19, 1993, 86 days after the submission was received.

What is the product code of K932520?

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