MULTI-SPECT— 510(k) K073021
Substantially EquivalentEagle Heart Imaging, LLC
FDA 510(k) clearance K073021 for MULTI-SPECT, Substantially Equivalent on 2007-11-06. Applicant: Eagle Heart Imaging, LLC. Device class: 2.
Clearance details
- Applicant
- Eagle Heart Imaging, LLC
- 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
- Westminster, CO, US
Recent devices under product code KPS
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