THE OSTEOREPORT— 510(k) K934040
Substantially EquivalentWoodson and Associates, LLC
FDA 510(k) clearance K934040 for THE OSTEOREPORT, Substantially Equivalent on 1994-09-26. Applicant: Woodson and Associates, LLC. Device class: 2.
Clearance details
- Applicant
- Woodson and Associates, LLC
- 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
- Decatur, GA, 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.