FDA 510(k)

电动轮椅（Robooter E40），型号名称：BBR-E40-01

K号: K231868 · 2023-10-31

决定日期2023-10-31

产品代码ITI

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决定实质等同

器械摘要

Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Bangbang Robotics Co., Ltd.. It received FDA 510(k) clearance on 2023-10-31 under 510(k) number K231868. 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 Electric Wheelchair (Robooter E40), Model name: BBR-E40-01?

Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 is a medical device that received FDA 510(k) clearance on 2023-10-31. The listed applicant is Shanghai Bangbang Robotics Co., Ltd.. The 510(k) number is K231868.

When did Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 receive FDA 510(k) clearance?

Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 received FDA 510(k) clearance on 2023-10-31, under 510(k) number K231868.

Who is the listed applicant for Electric Wheelchair (Robooter E40), Model name: BBR-E40-01?

The FDA 510(k) record lists Shanghai Bangbang Robotics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electric Wheelchair (Robooter E40), Model name: BBR-E40-01?

The FDA product code for Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 is ITI.

列明Shanghai Bangbang Robotics Co., Ltd.为申报人的其他记录

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官方来源

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