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FDA 510(k)

CYRTINA SYSTEM

K-Number: K063842 · 2007-04-17

ApplicantOratio B.V.
Decision Date2007-04-17
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CYRTINA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Oratio B.V.. It received FDA 510(k) clearance on 2007-04-17 under 510(k) number K063842. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYRTINA SYSTEM?

CYRTINA SYSTEM is a medical device that received FDA 510(k) clearance on 2007-04-17. The listed applicant is Oratio B.V.. The 510(k) number is K063842.

When did CYRTINA SYSTEM receive FDA 510(k) clearance?

CYRTINA SYSTEM received FDA 510(k) clearance on 2007-04-17, under 510(k) number K063842.

Who is the listed applicant for CYRTINA SYSTEM?

The FDA 510(k) record lists Oratio B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CYRTINA SYSTEM?

The FDA product code for CYRTINA SYSTEM is EIH.

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Related Devices (Code: EIH)

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Official Source

View on FDA Database →

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

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