FDA 510(k)

电动轮椅 DYW30A(D09)

K号: K170787 · 2017-08-09

申请人Nanjing Jin Bai HE Medical Apparatus Co., Ltd.

决定日期2017-08-09

产品代码ITI

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决定实质等同

器械摘要

Powered Wheelchair DYW30A(D09) is the device name listed in this FDA 510(k) record. The listed applicant is Nanjing Jin Bai HE Medical Apparatus Co., Ltd.. It received FDA 510(k) clearance on 2017-08-09 under 510(k) number K170787. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Powered Wheelchair DYW30A(D09)?

Powered Wheelchair DYW30A(D09) is a medical device that received FDA 510(k) clearance on 2017-08-09. The listed applicant is Nanjing Jin Bai HE Medical Apparatus Co., Ltd.. The 510(k) number is K170787.

When did Powered Wheelchair DYW30A(D09) receive FDA 510(k) clearance?

Powered Wheelchair DYW30A(D09) received FDA 510(k) clearance on 2017-08-09, under 510(k) number K170787.

Who is the listed applicant for Powered Wheelchair DYW30A(D09)?

The FDA 510(k) record lists Nanjing Jin Bai HE Medical Apparatus Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powered Wheelchair DYW30A(D09)?

The FDA product code for Powered Wheelchair DYW30A(D09) is ITI.

列明Nanjing Jin Bai HE Medical Apparatus Co., Ltd.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。

K201196滑板车（型号：FDB01）

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