FDA 510(k)

第二次意见

K号: K210365 · 2022-03-04

决定日期2022-03-04

产品代码MYN

咨询委员会RA

决定实质等同

器械摘要

Second Opinion is the device name listed in this FDA 510(k) record. The listed applicant is Pearl, Inc.. It received FDA 510(k) clearance on 2022-03-04 under 510(k) number K210365. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Second Opinion?

Second Opinion is a medical device that received FDA 510(k) clearance on 2022-03-04. The listed applicant is Pearl, Inc.. The 510(k) number is K210365.

When did Second Opinion receive FDA 510(k) clearance?

Second Opinion received FDA 510(k) clearance on 2022-03-04, under 510(k) number K210365.

Who is the listed applicant for Second Opinion?

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

What is the FDA product code for Second Opinion?

The FDA product code for Second Opinion is MYN.

列明Pearl, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K250525Second Opinion® Panoramic K243234Second Opinion® CS K243989Second Opinion® 3D K243230Second Opinion® BLE K243893Second Opinion® Pediatric K242600第二次意见根尖透照轮廓

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。