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FDA 510(k)

MASTERSCREEN PAED - BABY BODY

K-Number: K081823 · 2009-05-18

ApplicantViasys Healthcare GmbH
Decision Date2009-05-18
Product CodeCCM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MASTERSCREEN PAED - BABY 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 2009-05-18 under 510(k) number K081823. The device is classified under product code CCM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MASTERSCREEN PAED - BABY BODY?

MASTERSCREEN PAED - BABY BODY is a medical device that received FDA 510(k) clearance on 2009-05-18. The listed applicant is Viasys Healthcare GmbH. The 510(k) number is K081823.

When did MASTERSCREEN PAED - BABY BODY receive FDA 510(k) clearance?

MASTERSCREEN PAED - BABY BODY received FDA 510(k) clearance on 2009-05-18, under 510(k) number K081823.

Who is the listed applicant for MASTERSCREEN PAED - BABY 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 PAED - BABY BODY?

The FDA product code for MASTERSCREEN PAED - BABY BODY is CCM.

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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+K080510VIP PULMONARY FUNCTION SYSTEMK080734FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CTK072061MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY

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Related Devices (Code: CCM)

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.

K023796MS PAED-BABY BODYErich Jaeger GmbHK9432591085 ULTIMATE E PLETHYSMOGRAPHMedical Graphics Corp.K893420MASTERLAB PFT AND MASTERLAB BODY BOXQuinton, Inc.K853390INFANT BODY TESTErich Jaeger, Inc.K852102COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEMWarren E. Collins, Inc.K852088SYSTEM 1085 BODY PLETHYSMOGRAPHMedical Graphics Corp.

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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