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FDA 510(k)

ShenDa Sinuscope

K-Number: K161298 · 2017-08-25

ApplicantShenyang Shenda Endoscope Co., Ltd.
Decision Date2017-08-25
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ShenDa Sinuscope is a medical device manufactured by Shenyang Shenda Endoscope Co., Ltd.. It received FDA 510(k) clearance on 2017-08-25 under approval number K161298. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ShenDa Sinuscope?

ShenDa Sinuscope is a medical device that received FDA 510(k) clearance on 2017-08-25. It is manufactured by Shenyang Shenda Endoscope Co., Ltd.. The 510(k) number is K161298.

When was ShenDa Sinuscope approved by the FDA?

ShenDa Sinuscope received FDA 510(k) clearance on 2017-08-25, under approval number K161298.

What company makes ShenDa Sinuscope?

ShenDa Sinuscope is manufactured by Shenyang Shenda Endoscope Co., Ltd..

What is the FDA product code for ShenDa Sinuscope?

The FDA product code for ShenDa Sinuscope is EOB.

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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.

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