NON-CIRCULAR ORBITING OPTION— 510(k) K861252
Substantially EquivalentSiemens Gammasonics, Inc.
FDA 510(k) clearance K861252 for NON-CIRCULAR ORBITING OPTION, Substantially Equivalent on 1986-04-16. Applicant: Siemens Gammasonics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Gammasonics, 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
- Des Plaines, IL, US
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