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FDA 510(k)

CORSCREEN

K-Number: K070614 · 2007-05-04

ApplicantViasys Healthcare GmbH
Decision Date2007-05-04
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORSCREEN 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 2007-05-04 under 510(k) number K070614. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORSCREEN?

CORSCREEN is a medical device that received FDA 510(k) clearance on 2007-05-04. The listed applicant is Viasys Healthcare GmbH. The 510(k) number is K070614.

When did CORSCREEN receive FDA 510(k) clearance?

CORSCREEN received FDA 510(k) clearance on 2007-05-04, under 510(k) number K070614.

Who is the listed applicant for CORSCREEN?

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 CORSCREEN?

The FDA product code for CORSCREEN is DPS.

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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: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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