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FDA 510(k)

MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA

K-Number: K080582 · 2008-05-15

ApplicantMedicatech USA
Decision Date2008-05-15
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA is the device name listed in this FDA 510(k) record. The listed applicant is Medicatech USA. It received FDA 510(k) clearance on 2008-05-15 under 510(k) number K080582. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA?

MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA is a medical device that received FDA 510(k) clearance on 2008-05-15. The listed applicant is Medicatech USA. The 510(k) number is K080582.

When did MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA receive FDA 510(k) clearance?

MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA received FDA 510(k) clearance on 2008-05-15, under 510(k) number K080582.

Who is the listed applicant for MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA?

The FDA 510(k) record lists Medicatech USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA?

The FDA product code for MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA is KPR.

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Related Devices (Code: KPR)

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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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