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FDA 510(k)

DEXACARE G4

K-Number: K021331 · 2002-05-21

ApplicantOsteometer Meditech, Inc.
Decision Date2002-05-21
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DEXACARE G4 is the device name listed in this FDA 510(k) record. The listed applicant is Osteometer Meditech, Inc.. It received FDA 510(k) clearance on 2002-05-21 under 510(k) number K021331. The device is classified under product code KGI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEXACARE G4?

DEXACARE G4 is a medical device that received FDA 510(k) clearance on 2002-05-21. The listed applicant is Osteometer Meditech, Inc.. The 510(k) number is K021331.

When did DEXACARE G4 receive FDA 510(k) clearance?

DEXACARE G4 received FDA 510(k) clearance on 2002-05-21, under 510(k) number K021331.

Who is the listed applicant for DEXACARE G4?

The FDA 510(k) record lists Osteometer Meditech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEXACARE G4?

The FDA product code for DEXACARE G4 is KGI.

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Related Devices (Code: KGI)

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.

K254072BoneVueCurvebeam AI / Curvebeam, LLCK252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLCK2510223D-SHAPER3D-Shaper Medical S.LK242295BunkerHill BMDBunkerHill HealthK243218TBS iNsight (V4)Medimaps Group SAK220402VirtuOstO.N. Diagnostics

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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