EchoS— 510(k) K180516
Substantially EquivalentEcholight S.P.A
FDA 510(k) clearance K180516 for EchoS, Substantially Equivalent on 2018-10-19. Applicant: Echolight S.P.A. Device class: 2.
Clearance details
- Applicant
- Echolight S.P.A
- Product code
- Code MUA
- Device class
- Class 2
- Regulation
- 21 CFR 892.1180
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lecce, IT
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