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FDA 510(k)

MASTERSCREEN PNEUMO & MASTERSCOPE

K-Number: K071753 · 2007-08-14

ApplicantViasys Healthcare GmbH
Decision Date2007-08-14
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MASTERSCREEN PNEUMO & MASTERSCOPE 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 2007-08-14 under 510(k) number K071753. 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 MASTERSCREEN PNEUMO & MASTERSCOPE?

MASTERSCREEN PNEUMO & MASTERSCOPE is a medical device that received FDA 510(k) clearance on 2007-08-14. The listed applicant is Viasys Healthcare GmbH. The 510(k) number is K071753.

When did MASTERSCREEN PNEUMO & MASTERSCOPE receive FDA 510(k) clearance?

MASTERSCREEN PNEUMO & MASTERSCOPE received FDA 510(k) clearance on 2007-08-14, under 510(k) number K071753.

Who is the listed applicant for MASTERSCREEN PNEUMO & MASTERSCOPE?

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 MASTERSCREEN PNEUMO & MASTERSCOPE?

The FDA product code for MASTERSCREEN PNEUMO & MASTERSCOPE 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 SYSTEMK080734FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT

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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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