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FDA 510(k)

KATIA SYSTEM

K-Number: K131512 · 2013-08-07

ApplicantShanghai Sanyou Medical Co, Ltd.
Decision Date2013-08-07
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KATIA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Sanyou Medical Co, Ltd.. It received FDA 510(k) clearance on 2013-08-07 under 510(k) number K131512. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KATIA SYSTEM?

KATIA SYSTEM is a medical device that received FDA 510(k) clearance on 2013-08-07. The listed applicant is Shanghai Sanyou Medical Co, Ltd.. The 510(k) number is K131512.

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

KATIA SYSTEM received FDA 510(k) clearance on 2013-08-07, under 510(k) number K131512.

Who is the listed applicant for KATIA SYSTEM?

The FDA 510(k) record lists Shanghai Sanyou Medical Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KATIA SYSTEM?

The FDA product code for KATIA SYSTEM is KWQ.

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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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