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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

OTV-S5 OES VIDEO SYSTEM

Manufacturer

OLYMPUS AMERICA, INC.

Date Cleared

1996-02-01

(66 days)

Product Code

Regulation Number

Type

Panel

General & Plastic Surgery

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K042069,K083155,K971373,K971416

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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