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FDA 510(k)

THE OSTEOREPORT

K-Number: K934040 · 1994-09-26

ApplicantWoodson and Associates, LLC
Decision Date1994-09-26
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THE OSTEOREPORT is the device name listed in this FDA 510(k) record. The listed applicant is Woodson and Associates, LLC. It received FDA 510(k) clearance on 1994-09-26 under 510(k) number K934040. 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 THE OSTEOREPORT?

THE OSTEOREPORT is a medical device that received FDA 510(k) clearance on 1994-09-26. The listed applicant is Woodson and Associates, LLC. The 510(k) number is K934040.

When did THE OSTEOREPORT receive FDA 510(k) clearance?

THE OSTEOREPORT received FDA 510(k) clearance on 1994-09-26, under 510(k) number K934040.

Who is the listed applicant for THE OSTEOREPORT?

The FDA 510(k) record lists Woodson and Associates, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE OSTEOREPORT?

The FDA product code for THE OSTEOREPORT is KGI.

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Other records listing Woodson and Associates, LLC 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.

K981553AUTOMATED MEDICAL REPORT WRITER

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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