DYSIS— 510(k) K092433

Substantially Equivalent

Forth Photonics Hellas SA

FDA 510(k) clearance K092433 for DYSIS, Substantially Equivalent on 2011-03-10. Applicant: Forth Photonics Hellas SA. Device class: 2.

Clearance details

Applicant: Forth Photonics Hellas SA
Product code: Code HEX
Device class: Class 2
Regulation: 21 CFR 884.1630
Advisory panel: Obstetrics/Gynecology
Date received: 2009-08-07
Decision date: 2011-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canton, MA, US

Download summary PDF View on FDA.gov ↗

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