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FDA 510(k)

KAINOS+

K-Number: K090387 · 2009-09-28

ApplicantSignus Medizintechnik GmbH
Decision Date2009-09-28
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KAINOS+ is the device name listed in this FDA 510(k) record. The listed applicant is Signus Medizintechnik GmbH. It received FDA 510(k) clearance on 2009-09-28 under 510(k) number K090387. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KAINOS+?

KAINOS+ is a medical device that received FDA 510(k) clearance on 2009-09-28. The listed applicant is Signus Medizintechnik GmbH. The 510(k) number is K090387.

When did KAINOS+ receive FDA 510(k) clearance?

KAINOS+ received FDA 510(k) clearance on 2009-09-28, under 510(k) number K090387.

Who is the listed applicant for KAINOS+?

The FDA 510(k) record lists Signus Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KAINOS+?

The FDA product code for KAINOS+ is MQV.

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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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