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510(k) Data Aggregation

K Number

Device Name

ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)

Manufacturer

OriGyn Medical Technology (Hangzhou) Co., Ltd.

Date Cleared

2024-07-26

(168 days)

Product Code

HIH

Regulation Number

884.1690

Why did this record match?

Applicant Name (Manufacturer) :

OriGyn Medical Technology (Hangzhou) Co., Ltd.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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