CLARUS (700)— 510(k) K243878
Substantially EquivalentCarl Zeiss Meditec, Inc.
FDA 510(k) clearance K243878 for CLARUS (700), Substantially Equivalent on 2025-04-17. Applicant: Carl Zeiss Meditec, Inc.. Device class: 2.
Clearance details
- Applicant
- Carl Zeiss Meditec, Inc.
- Product code
- Code QER
- Device class
- Class 2
- Regulation
- 21 CFR 886.1120
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dublin, CA, US
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