Name: Predicase
Price: 199 USD

K-number	K232003
Device name	Endoscopic Video Image Processor, Single-Use Video Hysteroscope
Applicant	Guangzhou Red Pine Medical Instrument Co., Ltd.
Product code	HIH
Device class	Class II
Decision date	Feb 12, 2024
Decision	Substantially Equivalent
Regulation	884.1690

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Source

View the full FDA submission: accessdata.fda.gov

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Endoscopic Video Image Processor, Single-Use Video Hysteroscope

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