FDA 510(k)

REVEAL Bulk

K号: K171147 · 2017-08-04

决定日期2017-08-04

产品代码EBF

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决定实质等同

器械摘要

REVEAL Bulk is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2017-08-04 under 510(k) number K171147. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the REVEAL Bulk?

REVEAL Bulk is a medical device that received FDA 510(k) clearance on 2017-08-04. The listed applicant is Bisco, Inc.. The 510(k) number is K171147.

When did REVEAL Bulk receive FDA 510(k) clearance?

REVEAL Bulk received FDA 510(k) clearance on 2017-08-04, under 510(k) number K171147.

Who is the listed applicant for REVEAL Bulk?

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

What is the FDA product code for REVEAL Bulk?

The FDA product code for REVEAL Bulk is EBF.

列明Bisco, 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。

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