AT 030— 510(k) K180839

Clearance details

Applicant

Carl Zeiss Meditec, AG

Product code

Code HKY

Device class

Class 2

Regulation

21 CFR 886.1930

Advisory panel

Ophthalmic

Date received

2018-03-30

Decision date

2018-06-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Jena, DE

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