CALLISTO EYE— 510(k) K123464
Substantially EquivalentCarl Zeiss Meditec, AG
FDA 510(k) clearance K123464 for CALLISTO EYE, Substantially Equivalent on 2013-03-05. 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
- Dublin, CA, US
Recent devices under product code NFJ
view allMore clearances from Carl Zeiss Meditec, AG
view allData sourced from openFDA. This site is unofficial and independent of the FDA.