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FDA 510(k)

CIRRUS OPEN

K-Number: K090080 · 2009-03-23

ApplicantMri-Tech Sp. Zo.O.
Decision Date2009-03-23
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CIRRUS OPEN is the device name listed in this FDA 510(k) record. The listed applicant is Mri-Tech Sp. Zo.O.. It received FDA 510(k) clearance on 2009-03-23 under 510(k) number K090080. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIRRUS OPEN?

CIRRUS OPEN is a medical device that received FDA 510(k) clearance on 2009-03-23. The listed applicant is Mri-Tech Sp. Zo.O.. The 510(k) number is K090080.

When did CIRRUS OPEN receive FDA 510(k) clearance?

CIRRUS OPEN received FDA 510(k) clearance on 2009-03-23, under 510(k) number K090080.

Who is the listed applicant for CIRRUS OPEN?

The FDA 510(k) record lists Mri-Tech Sp. Zo.O. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CIRRUS OPEN?

The FDA product code for CIRRUS OPEN is LNH.

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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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