NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS— 510(k) K973459

Substantially Equivalent

Norland Corp.

FDA 510(k) clearance K973459 for NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS, Substantially Equivalent on 1998-02-13. Applicant: Norland Corp..

Clearance details

Applicant: Norland Corp.
Product code: Code KGI
Advisory panel: Radiology
Date received: 1997-09-12
Decision date: 1998-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Atkinson, WI, US

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Adverse events under product code KGI

product code KGI

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.