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FDA 510(k)

GRINDCARE MEASURE

K-Number: K113677 · 2012-04-05

ApplicantMedotech A/S
Decision Date2012-04-05
Product CodeKZM
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

GRINDCARE MEASURE is the device name listed in this FDA 510(k) record. The listed applicant is Medotech A/S. It received FDA 510(k) clearance on 2012-04-05 under 510(k) number K113677. The device is classified under product code KZM. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRINDCARE MEASURE?

GRINDCARE MEASURE is a medical device that received FDA 510(k) clearance on 2012-04-05. The listed applicant is Medotech A/S. The 510(k) number is K113677.

When did GRINDCARE MEASURE receive FDA 510(k) clearance?

GRINDCARE MEASURE received FDA 510(k) clearance on 2012-04-05, under 510(k) number K113677.

Who is the listed applicant for GRINDCARE MEASURE?

The FDA 510(k) record lists Medotech A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GRINDCARE MEASURE?

The FDA product code for GRINDCARE MEASURE is KZM.

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Other records listing Medotech A/S 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.

K092675GRINDCARE

Related Devices (Code: KZM)

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.

K161716TEETHAN 2.0Bts S.P.A.K130158M-SCANBio-Research Associates, Inc.K082927BIOEMG IIIBio-Research Associates, Inc.K043373DOLOTENS DENTAL TM 1Neuromuscular Technologies, Inc.K030869BITESTRIPS.L.P. , Ltd.K003176BIOEMG II AND BIOJVABio-Research Associates, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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