CARDIAC SCANNER AND PROCESSING SYSTEM— 510(k) K110507
Substantially EquivalentSpectrum Dynamics (Israel) , Ltd.
FDA 510(k) clearance K110507 for CARDIAC SCANNER AND PROCESSING SYSTEM, Substantially Equivalent on 2011-07-13. Applicant: Spectrum Dynamics (Israel) , Ltd..
Clearance details
- Applicant
- Spectrum Dynamics (Israel) , Ltd.
- Product code
- Code KPS
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zichron Yaacov, IL
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