FDA 510(k)

Wearable Breast Pump,Model S18

K番号: K232774 · 2024-06-06

申請者Ningbo Dearevery Electronic Technology Co., Ltd.

決定日2024-06-06

製品コードHGX

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OB [翻訳] OB

決定Substantially Equivalent

医療機器の概要

Wearable Breast Pump,Model S18 is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Dearevery Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-06-06 under 510(k) number K232774. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Wearable Breast Pump,Model S18?

Wearable Breast Pump,Model S18 is a medical device that received FDA 510(k) clearance on 2024-06-06. The listed applicant is Ningbo Dearevery Electronic Technology Co., Ltd.. The 510(k) number is K232774.

When did Wearable Breast Pump,Model S18 receive FDA 510(k) clearance?

Wearable Breast Pump,Model S18 received FDA 510(k) clearance on 2024-06-06, under 510(k) number K232774.

Who is the listed applicant for Wearable Breast Pump,Model S18?

The FDA 510(k) record lists Ningbo Dearevery Electronic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wearable Breast Pump,Model S18?

The FDA product code for Wearable Breast Pump,Model S18 is HGX.

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Wearable Breast Pump,Model S18

医療機器の概要

よくある質問

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