ROTA CAMERA— 510(k) K811715
Substantially EquivalentSiemens Gammasonics, Inc.
FDA 510(k) clearance K811715 for ROTA CAMERA, Substantially Equivalent on 1981-07-20. Applicant: Siemens Gammasonics, Inc.. Device class: 1.
Clearance details
- Applicant
- Siemens Gammasonics, Inc.
- Product code
- Code IYX
- Device class
- Class 1
- Regulation
- 21 CFR 892.1100
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code IYX
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