FDA 510(k)

imani i2

K号: K202037 · 2021-03-01

决定日期2021-03-01

产品代码HGX

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决定实质等同

器械摘要

imani i2 is the device name listed in this FDA 510(k) record. The listed applicant is Imani Co.. It received FDA 510(k) clearance on 2021-03-01 under 510(k) number K202037. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the imani i2?

imani i2 is a medical device that received FDA 510(k) clearance on 2021-03-01. The listed applicant is Imani Co.. The 510(k) number is K202037.

When did imani i2 receive FDA 510(k) clearance?

imani i2 received FDA 510(k) clearance on 2021-03-01, under 510(k) number K202037.

Who is the listed applicant for imani i2?

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

What is the FDA product code for imani i2?

The FDA product code for imani i2 is HGX.

列明Imani Co.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。

K222573imani i2Plus 乳腺泵 K202045imani i1

相关器械（代码：HGX）

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。

K254203可穿戴式乳腺泵（型号S36）Shenzhen TPH Technology Co., Ltd.K261622飞利浦新安怡自然护理免手提电动吸奶器（型号：SCF593/52，SCF593/62）；飞利浦新安怡自然护理加热免手提电动吸奶器（型号：SCF594/52，SCF594/62）Philips Consumer Lifestyle B.V.K262774可穿戴式乳腺泵（型号：XN/MD-2249BS，ZFHF）Guangdong Horigen Mother & Baby Products Co., Ltd.K260643Cimilre 双重最大Cimilre Co., Ltd.K261298可穿戴电动吸奶器（YM-8837，YM-8838，YM-8856(H03)，YM-8809(S42)）Guangdong Youmeng Electrical Technology Co., Ltd.K260259DiscreetDuo™ 流动式穿戴型乳房吸奶器（型号 S3）Shenzhen TPH Technology Co., Ltd.

官方来源

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