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FDA 510(k)

MASTERSCREEN CPX AND OXYCON CPX

K-Number: K040698 · 2004-04-07

ApplicantViasys Healthcare GmbH
Decision Date2004-04-07
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MASTERSCREEN CPX AND OXYCON CPX 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 2004-04-07 under 510(k) number K040698. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MASTERSCREEN CPX AND OXYCON CPX?

MASTERSCREEN CPX AND OXYCON CPX is a medical device that received FDA 510(k) clearance on 2004-04-07. The listed applicant is Viasys Healthcare GmbH. The 510(k) number is K040698.

When did MASTERSCREEN CPX AND OXYCON CPX receive FDA 510(k) clearance?

MASTERSCREEN CPX AND OXYCON CPX received FDA 510(k) clearance on 2004-04-07, under 510(k) number K040698.

Who is the listed applicant for MASTERSCREEN CPX AND OXYCON CPX?

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 CPX AND OXYCON CPX?

The FDA product code for MASTERSCREEN CPX AND OXYCON CPX is BZC.

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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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