DEXACARE G4— 510(k) K021331
Substantially EquivalentOsteometer Meditech, Inc.
FDA 510(k) clearance K021331 for DEXACARE G4, Substantially Equivalent on 2002-05-21. Applicant: Osteometer Meditech, Inc.. Device class: 2.
Clearance details
- Applicant
- Osteometer Meditech, Inc.
- 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
- Special
- Location
- Hawthorne, CA, US
Recent devices under product code KGI
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.