FDA.report

510(k) K231676

Device
CALLISTO eye
Applicant
Carl Zeiss Meditec, AG
510(k) number
K231676
Product code
NFJ
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-28
Date received
2023-06-09
Regulation
892.2050
Classification name
System, Image Management, Ophthalmic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Hans-Joachim Miesner
Address
Goeschwitzer Strasse 51-52 Jena DE 07745 07745

FDA Registration Numbers

Source Documents

510(k) summary PDF

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