FDA 510(k)

Erisma LP Navigated Instruments

K号: K202956 · 2021-02-26

决定日期2021-02-26

产品代码OLO

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决定实质等同

器械摘要

Erisma LP Navigated Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Clariance, Sas. It received FDA 510(k) clearance on 2021-02-26 under 510(k) number K202956. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Erisma LP Navigated Instruments?

Erisma LP Navigated Instruments is a medical device that received FDA 510(k) clearance on 2021-02-26. The listed applicant is Clariance, Sas. The 510(k) number is K202956.

When did Erisma LP Navigated Instruments receive FDA 510(k) clearance?

Erisma LP Navigated Instruments received FDA 510(k) clearance on 2021-02-26, under 510(k) number K202956.

Who is the listed applicant for Erisma LP Navigated Instruments?

The FDA 510(k) record lists Clariance, Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Erisma LP Navigated Instruments?

The FDA product code for Erisma LP Navigated Instruments is OLO.

列明Clariance, Sas为申报人的其他记录

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