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FDA 510(k)

CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000

K-Number: K052473 · 2005-10-28

ApplicantInter Medical Medizintechnik GmbH
Decision Date2005-10-28
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000 is the device name listed in this FDA 510(k) record. The listed applicant is Inter Medical Medizintechnik GmbH. It received FDA 510(k) clearance on 2005-10-28 under 510(k) number K052473. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000?

CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000 is a medical device that received FDA 510(k) clearance on 2005-10-28. The listed applicant is Inter Medical Medizintechnik GmbH. The 510(k) number is K052473.

When did CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000 receive FDA 510(k) clearance?

CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000 received FDA 510(k) clearance on 2005-10-28, under 510(k) number K052473.

Who is the listed applicant for CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000?

The FDA 510(k) record lists Inter Medical Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000?

The FDA product code for CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000 is IYX.

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Other records listing Inter Medical Medizintechnik GmbH as applicant

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Related Devices (Code: IYX)

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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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