CALLISTO eye— 510(k) K180858
Substantially EquivalentCarl Zeiss Meditec, AG
FDA 510(k) clearance K180858 for CALLISTO eye, Substantially Equivalent on 2018-06-27. Applicant: Carl Zeiss Meditec, AG. Device class: 2.
Clearance details
- Applicant
- Carl Zeiss Meditec, AG
- Product code
- Code NFJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jena, DE
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