PLEX Elite 9000 SS-OCT— 510(k) K161194

Substantially Equivalent

Carl Zeiss Meditec, Inc.

FDA 510(k) clearance K161194 for PLEX Elite 9000 SS-OCT, Substantially Equivalent on 2016-10-26. Applicant: Carl Zeiss Meditec, Inc..

Clearance details

Applicant: Carl Zeiss Meditec, Inc.
Product code: Code OBO
Advisory panel: Ophthalmic
Date received: 2016-04-27
Decision date: 2016-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dublin, CA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.