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FDA 510(k)

TRAUS SIP20

K-Number: K201292 · 2021-02-11

Decision Date2021-02-11
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TRAUS SIP20 is a medical device manufactured by Saeshin Precision Co., Ltd.. It received FDA 510(k) clearance on 2021-02-11 under approval number K201292. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAUS SIP20?

TRAUS SIP20 is a medical device that received FDA 510(k) clearance on 2021-02-11. It is manufactured by Saeshin Precision Co., Ltd.. The 510(k) number is K201292.

When was TRAUS SIP20 approved by the FDA?

TRAUS SIP20 received FDA 510(k) clearance on 2021-02-11, under approval number K201292.

What company makes TRAUS SIP20?

TRAUS SIP20 is manufactured by Saeshin Precision Co., Ltd..

What is the FDA product code for TRAUS SIP20?

The FDA product code for TRAUS SIP20 is EBW.

Other Devices by Saeshin Precision Co., Ltd.

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Related Devices (Code: EBW)

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.