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FDA 510(k)

FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT

K-Number: K080734 · 2008-06-26

ApplicantViasys Healthcare GmbH
Decision Date2008-06-26
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT 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 2008-06-26 under 510(k) number K080734. 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 FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT?

FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT is a medical device that received FDA 510(k) clearance on 2008-06-26. The listed applicant is Viasys Healthcare GmbH. The 510(k) number is K080734.

When did FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT receive FDA 510(k) clearance?

FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT received FDA 510(k) clearance on 2008-06-26, under 510(k) number K080734.

Who is the listed applicant for FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT?

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 FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT?

The FDA product code for FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT 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 BODYK080510VIP PULMONARY FUNCTION SYSTEMK072061MASTERSCREEN 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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