System 84 Computerized Lung Vol. Spirom

FDA 510(k) K810196 · Cardio Pulmonary Instruments

Substantially Equivalent

510(k) numberK810196

Submission

Device name
System 84 Computerized Lung Vol. Spirom
Applicant
Cardio Pulmonary Instruments
Mchenry, IL, US
Received
January 23, 1981
Decision date
February 5, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

Other 510(k)s with product code BZC

510(k)DeviceApplicantDecision
K240293STSBZC · Traditional Techbopulm, Ltd.09/17/2024SE
K183567Vyntus/SentrySuite Product LineBZC · Traditional Vyaire Medical08/23/2019SE
K190853Vyntus BODYBZC · Traditional Vyaire Medical, Inc.08/16/2019SE
K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART…BZC · Traditional Vyaire Medical, Inc.11/30/2018SE
K162515COSMED K5 Wearable Metabolic TechnologyBZC · Traditional Cosmed Srl06/20/2017SE
K161295MiniBox +BZC · Traditional Pulmone Advanced Medical Devices, Ltd.10/21/2016SE
K150810Vyntus / SentrySuite Product LineBZC · Traditional Carefusion Germany 234 GmbH08/14/2015SE
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

510(k)DeviceDecision
K810243System 86 Computerized Lung Vol. SpiromeBZC · Traditional 02/12/1981SE
K803255Automated Pulmonary Function LaboratoryBZC · Traditional 01/28/1981SE

Questions and answers

When was System 84 Computerized Lung Vol. Spirom cleared by the FDA?

System 84 Computerized Lung Vol. Spirom (K810196) received a 510(k) decision of Substantially Equivalent on February 5, 1981, 13 days after the submission was received.

What is the product code of K810196?

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