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FDA 510(k)

ACCUDEXA BONE DENSITOMETER

K-Number: K971735 · 1997-12-02

ApplicantSchick Technologies, Inc.
Decision Date1997-12-02
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACCUDEXA BONE DENSITOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Schick Technologies, Inc.. It received FDA 510(k) clearance on 1997-12-02 under 510(k) number K971735. 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 ACCUDEXA BONE DENSITOMETER?

ACCUDEXA BONE DENSITOMETER is a medical device that received FDA 510(k) clearance on 1997-12-02. The listed applicant is Schick Technologies, Inc.. The 510(k) number is K971735.

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

ACCUDEXA BONE DENSITOMETER received FDA 510(k) clearance on 1997-12-02, under 510(k) number K971735.

Who is the listed applicant for ACCUDEXA BONE DENSITOMETER?

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

What is the FDA product code for ACCUDEXA BONE DENSITOMETER?

The FDA product code for ACCUDEXA BONE DENSITOMETER is KGI.

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Other records listing Schick Technologies, 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.

K110768COMPUTED DENTAL RADIOGRAPHYK093453MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMK072134SCHICK COMPUTED ORAL RADIOLOGY SYSTEMK053558CEPH, MODEL 4900K041385MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMK031291CDR PANX, MODEL 4792

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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

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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