Fluorescence Mode— 510(k) K171007

Substantially Equivalent

Carl Zeiss Suzhou Co., Ltd.

FDA 510(k) clearance K171007 for Fluorescence Mode, Substantially Equivalent on 2018-05-03. Applicant: Carl Zeiss Suzhou Co., Ltd.. Device class: 2.

Clearance details

Applicant: Carl Zeiss Suzhou Co., Ltd.
Product code: Code NBL
Device class: Class 2
Regulation: 21 CFR 872.1745
Advisory panel: Dental
Date received: 2017-04-04
Decision date: 2018-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

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