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FDA 510(k)

MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY

K-Number: K072061 · 2008-04-22

ApplicantViasys Healthcare GmbH
Decision Date2008-04-22
Product CodeJEH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY 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 2008-04-22 under 510(k) number K072061. The device is classified under product code JEH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY?

MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY is a medical device that received FDA 510(k) clearance on 2008-04-22. The listed applicant is Viasys Healthcare GmbH. The 510(k) number is K072061.

When did MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY receive FDA 510(k) clearance?

MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY received FDA 510(k) clearance on 2008-04-22, under 510(k) number K072061.

Who is the listed applicant for MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY?

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 PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY?

The FDA product code for MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY is JEH.

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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: JEH)

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.

K240706PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)Ganshorn Medizin Electronic GmbHK223818Model 9160 VitaloQUBVitalograph Ireland, Ltd.K022636BODY BOX 5500Morgan Scientific, Inc.K960840C.E. VASCULAR MACHINEC.E. Diagnosis, Inc.K953642AP-18Jeneric/Pentron, Inc.K951901MASTERSCREEN PFT BODYErich Jaeger GmbH & Co. KG

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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