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FDA 510(k)

ISKRA MEDICAL GREEN IRF PRESTIGE

K-Number: K083590 · 2009-04-17

ApplicantIskra Medical, D.O.O.
Decision Date2009-04-17
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ISKRA MEDICAL GREEN IRF PRESTIGE is the device name listed in this FDA 510(k) record. The listed applicant is Iskra Medical, D.O.O.. It received FDA 510(k) clearance on 2009-04-17 under 510(k) number K083590. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISKRA MEDICAL GREEN IRF PRESTIGE?

ISKRA MEDICAL GREEN IRF PRESTIGE is a medical device that received FDA 510(k) clearance on 2009-04-17. The listed applicant is Iskra Medical, D.O.O.. The 510(k) number is K083590.

When did ISKRA MEDICAL GREEN IRF PRESTIGE receive FDA 510(k) clearance?

ISKRA MEDICAL GREEN IRF PRESTIGE received FDA 510(k) clearance on 2009-04-17, under 510(k) number K083590.

Who is the listed applicant for ISKRA MEDICAL GREEN IRF PRESTIGE?

The FDA 510(k) record lists Iskra Medical, D.O.O. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISKRA MEDICAL GREEN IRF PRESTIGE?

The FDA product code for ISKRA MEDICAL GREEN IRF PRESTIGE is GEI.

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Official Source

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