QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT)— 510(k) K003358
Substantially EquivalentSmv America
FDA 510(k) clearance K003358 for QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT), Substantially Equivalent on 2001-01-19. Applicant: Smv America. Device class: 2.
Clearance details
- Applicant
- Smv America
- 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
- Twinsburg, OH, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.