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FDA 510(k)

DYSIS

K-Number: K092433 · 2011-03-10

ApplicantForth Photonics Hellas SA
Decision Date2011-03-10
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Forth Photonics Hellas SA. It received FDA 510(k) clearance on 2011-03-10 under 510(k) number K092433. The device is classified under product code HEX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYSIS?

DYSIS is a medical device that received FDA 510(k) clearance on 2011-03-10. The listed applicant is Forth Photonics Hellas SA. The 510(k) number is K092433.

When did DYSIS receive FDA 510(k) clearance?

DYSIS received FDA 510(k) clearance on 2011-03-10, under 510(k) number K092433.

Who is the listed applicant for DYSIS?

The FDA 510(k) record lists Forth Photonics Hellas SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYSIS?

The FDA product code for DYSIS is HEX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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