FDA.report

510(k) K233933

Device
CIRRUS? HD-OCT Model 6000
Applicant
Carl Zeiss Meditec, Inc.
510(k) number
K233933
Product code
OBO
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-17
Date received
2023-12-14
Regulation
886.1570
Classification name
Tomography, Optical Coherence
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Vidita Desai
Address
5300 Central Pkwy. Dublin CA US 94568 94568

FDA Registration Numbers

Source Documents

510(k) summary PDF

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