SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS— 510(k) K002105
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K002105 for SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS, Substantially Equivalent on 2000-12-05. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code MLD
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danvers, MA, US
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