FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS— 510(k) K983271
Substantially EquivalentLunar Corp.
FDA 510(k) clearance K983271 for FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS, Substantially Equivalent on 1998-11-18. Applicant: Lunar Corp.. Device class: 2.
Clearance details
- Applicant
- Lunar Corp.
- Product code
- Code KGI
- Device class
- Class 2
- Regulation
- 21 CFR 892.1170
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Madison, WI, US
Recent devices under product code KGI
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view allAdverse events under product code KGI
product code KGI- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . 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.