Discovery MI Gen2— 510(k) K211846
Substantially EquivalentGe Medical Systems, LLC
FDA 510(k) clearance K211846 for Discovery MI Gen2, Substantially Equivalent on 2021-08-20. Applicant: Ge Medical Systems, LLC. Device class: 2.
Clearance details
- Applicant
- Ge Medical Systems, 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
- Waukesha, WI, US
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