APOLLO— 510(k) K972882
Substantially EquivalentNorland Corp.
FDA 510(k) clearance K972882 for APOLLO, Substantially Equivalent on 1997-10-31. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Atkinson, WI, US
Recent devices under product code KGI
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- K980125 — REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER
- K973459 — NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS
- K973104 — NORLAND MODEL PDEXA BONE DENSITOMETER
Adverse 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.