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

Name: FDA 510(k) clearance K973459
Creator: U.S. Food and Drug Administration
Published: 1998-02-13

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.. Device class: 2.

Clearance details

Applicant: Norland Corp.
Product code: Code KGI
Device class: Class 2
Regulation: 21 CFR 892.1170
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.