FDA 510(k)

BTL-899

K号: K192224 · 2019-12-05

申请人Btl

决定日期2019-12-05

产品代码GEI

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决定实质等同

器械摘要

BTL-899 is the device name listed in this FDA 510(k) record. The listed applicant is Btl. It received FDA 510(k) clearance on 2019-12-05 under 510(k) number K192224. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BTL-899?

BTL-899 is a medical device that received FDA 510(k) clearance on 2019-12-05. The listed applicant is Btl. The 510(k) number is K192224.

When did BTL-899 receive FDA 510(k) clearance?

BTL-899 received FDA 510(k) clearance on 2019-12-05, under 510(k) number K192224.

Who is the listed applicant for BTL-899?

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

What is the FDA product code for BTL-899?

The FDA product code for BTL-899 is GEI.

列明Btl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。

K202199BTL-899ST K200382BTL-703-2 K193201BTL-785F

相关器械（代码：GEI）

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。

K254196HARMONIC 1100 剪刀（HAR1120）；HARMONIC 1100 剪刀（HAR1136）Ethicon Endo-Surgery, LLC K261959Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，70mm刀片，推钮开关（0703-046-100）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，推钮开关，大批量非无菌（0703-046-102）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，70mm刀片，旋转开关（0703-047-100）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，旋转开关，大批量非无菌（0703-047-102）Stryker Instruments K261070LigaSure™ RAS 马里兰州颚部血管封合/分割器，纳米涂层Covidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364艾利安谜团射频设备Ellian Corp K253859Scarlet Pro（Scarlet Pro）VIOL Co., Ltd.

官方来源

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