MIE - GAMMA CAMERA SYSTEMS— 510(k) K053086
Substantially EquivalentMie America, Inc.
FDA 510(k) clearance K053086 for MIE - GAMMA CAMERA SYSTEMS, Substantially Equivalent on 2006-01-27. Applicant: Mie America, Inc.. Device class: 2.
Clearance details
- Applicant
- Mie America, Inc.
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elk Grove Village, IL, US
Recent devices under product code KPS
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