FDA 510(k), K161682, GE Lunar DXA Bone Densitometers with enCORE version 17

FDA 510(k), K161682, GE Lunar DXA Bone Densitometers with enCORE version 17

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510(K) Number: K161682
Device Name: GE Lunar DXA Bone Densitometers with enCORE version 17
Manufacturer:
Device Classification Name: Densitometer, Bone
Regulation Number: 892.1170
Classification Product Code: KGI
Date Received: 06/17/2016
Decision Date: 12/02/2016
Regulation Medical Specialty: Radiology

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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