OMNI DIAGNOST— 510(k) K874113
Substantially EquivalentXre Corp.
FDA 510(k) clearance K874113 for OMNI DIAGNOST, Substantially Equivalent on 1987-11-16. Applicant: Xre Corp.. Device class: 2.
Clearance details
- Applicant
- Xre Corp.
- Product code
- Code IXR
- Device class
- Class 2
- Regulation
- 21 CFR 892.1980
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Littleton, MA, US
Recent devices under product code IXR
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