FDA 510(k)

Second Opinion® BLE

K号: K243230 · 2025-05-09

决定日期2025-05-09

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

Second Opinion® BLE is the device name listed in this FDA 510(k) record. The listed applicant is Pearl, Inc.. It received FDA 510(k) clearance on 2025-05-09 under 510(k) number K243230. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Second Opinion® BLE?

Second Opinion® BLE is a medical device that received FDA 510(k) clearance on 2025-05-09. The listed applicant is Pearl, Inc.. The 510(k) number is K243230.

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

Second Opinion® BLE received FDA 510(k) clearance on 2025-05-09, under 510(k) number K243230.

Who is the listed applicant for Second Opinion® BLE?

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® BLE?

The FDA product code for Second Opinion® BLE is QIH.

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 K243893Second Opinion® Pediatric K242600第二次意见根尖透照轮廓 K242522第二次意见 CC

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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。