MODIFICATION TO SCINTRON IV— 510(k) K101013
Substantially EquivalentMiegmbh
FDA 510(k) clearance K101013 for MODIFICATION TO SCINTRON IV, Substantially Equivalent on 2010-06-07. Applicant: Miegmbh. Device class: 2.
Clearance details
- Applicant
- Miegmbh
- 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
- Special
- Location
- Elk Grove Village, IL, US
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