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FDA 510(k)

TRAUS SUS20

K-Number: K192561 · 2020-07-13

Decision Date2020-07-13
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TRAUS SUS20 is a medical device manufactured by Saeshin Precision Co., Ltd.. It received FDA 510(k) clearance on 2020-07-13 under approval number K192561. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAUS SUS20?

TRAUS SUS20 is a medical device that received FDA 510(k) clearance on 2020-07-13. It is manufactured by Saeshin Precision Co., Ltd.. The 510(k) number is K192561.

When was TRAUS SUS20 approved by the FDA?

TRAUS SUS20 received FDA 510(k) clearance on 2020-07-13, under approval number K192561.

What company makes TRAUS SUS20?

TRAUS SUS20 is manufactured by Saeshin Precision Co., Ltd..

What is the FDA product code for TRAUS SUS20?

The FDA product code for TRAUS SUS20 is DZI.

Other Devices by Saeshin Precision Co., Ltd.

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Related Devices (Code: DZI)

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.