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FDA 510(k)

OSTEOGRAM BONE DENSITOMETER

K-Number: K984285 · 1999-05-19

ApplicantCompumed, Inc.
Decision Date1999-05-19
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OSTEOGRAM BONE DENSITOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Compumed, Inc.. It received FDA 510(k) clearance on 1999-05-19 under 510(k) number K984285. 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 OSTEOGRAM BONE DENSITOMETER?

OSTEOGRAM BONE DENSITOMETER is a medical device that received FDA 510(k) clearance on 1999-05-19. The listed applicant is Compumed, Inc.. The 510(k) number is K984285.

When did OSTEOGRAM BONE DENSITOMETER receive FDA 510(k) clearance?

OSTEOGRAM BONE DENSITOMETER received FDA 510(k) clearance on 1999-05-19, under 510(k) number K984285.

Who is the listed applicant for OSTEOGRAM BONE DENSITOMETER?

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

What is the FDA product code for OSTEOGRAM BONE DENSITOMETER?

The FDA product code for OSTEOGRAM BONE DENSITOMETER is KGI.

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Other records listing Compumed, Inc. 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.

K955708COMPUMED DICON CLIENTK863965KENZ-ECG 102K854626COMPUMED PULMONARY FUNCTION ANALYZER MODEL 307BK802272COMPUTER ECG TERMINALK771648COMPUTER ECG TERMINAL

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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