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FDA 510(k)

VIP PULMONARY FUNCTION SYSTEM

K-Number: K080510 · 2008-08-20

ApplicantViasys Healthcare GmbH
Decision Date2008-08-20
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VIP PULMONARY FUNCTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Viasys Healthcare GmbH. It received FDA 510(k) clearance on 2008-08-20 under 510(k) number K080510. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIP PULMONARY FUNCTION SYSTEM?

VIP PULMONARY FUNCTION SYSTEM is a medical device that received FDA 510(k) clearance on 2008-08-20. The listed applicant is Viasys Healthcare GmbH. The 510(k) number is K080510.

When did VIP PULMONARY FUNCTION SYSTEM receive FDA 510(k) clearance?

VIP PULMONARY FUNCTION SYSTEM received FDA 510(k) clearance on 2008-08-20, under 510(k) number K080510.

Who is the listed applicant for VIP PULMONARY FUNCTION SYSTEM?

The FDA 510(k) record lists Viasys Healthcare GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIP PULMONARY FUNCTION SYSTEM?

The FDA product code for VIP PULMONARY FUNCTION SYSTEM is BTY.

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Other records listing Viasys Healthcare GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K092324SPIROPROK091412CLEAN PEAK FLOW METERK091505COR12+K081823MASTERSCREEN PAED - BABY BODYK080734FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CTK072061MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY

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Related Devices (Code: BTY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260242CPETWise PlatformMedibyt , Ltd.K242809Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics CorporationK223629SpiroSphere, SpiroSphereECG, CardioSphereEresearchtechnology GmbHK231561Pulmonary Function Tester, Model: A9Guangzhou Homesun Medical Technology Co., Ltd.K222982Virtus Metabolic MonitorVirtus Technology ApsK221030Model 9100 PFT/DICOVitalograph Ireland, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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