Lung Diffusion

FDA 510(k) K942864 · Nordan Smith Welding Supplies

Substantially Equivalent

510(k) numberK942864

Submission

Device name
Lung Diffusion
Applicant
Nordan Smith Welding Supplies
Hattiesburg, MS, US
Received
June 17, 1994
Decision date
March 3, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
BZC – Calculator, Pulmonary Function Data
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1880
Specialty
Anesthesiology

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K133925Vyntus/ Sentrysuite Product LineBZC · Traditional Carefusion Germany 234 GmbH08/22/2014SE
K133051Pulmone Minibox PFT TMBZC · Traditional Pulmone Advanced Medical Devices, Ltd.05/02/2014SE
K102047Lci Option for InnocorBZC · Traditional Innovision A/S11/01/2011SE

More from Innovision A/S

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K942866Clinical Blood Gas MixtureBXK · Traditional 09/01/1994SE
K942865Laser Gas MixtureGEX · Traditional 08/23/1994SE

Questions and answers

When was Lung Diffusion cleared by the FDA?

Lung Diffusion (K942864) received a 510(k) decision of Substantially Equivalent on March 3, 1995, 259 days after the submission was received.

What is the product code of K942864?

The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.