Name: Predicase
Price: 199 USD

K-number	K231969
Device name	BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)
Applicant	Dongguanshi Yiyingmei Technology Co., Ltd.
Product code	HGX
Device class	Class II
Decision date	Aug 30, 2024
Decision	Substantially Equivalent
Regulation	884.5160

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Source

View the full FDA submission: accessdata.fda.gov

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BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)

Everything you need for a 510(k) submission. Nothing you don't.