OPTUS OTOSCOPES

• K Number: K945264
• Device Name: OPTUS OTOSCOPES
• Manufacturer: OPTUS, INC.
• Date Cleared: 1996-02-02 ( 462 days)
• Product Code: ERA
• Regulation Number: 874.4770

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 874.4770 Otoscope.

(a)
Identification. An otoscope is a device intended to allow inspection of the external ear canal and tympanic membrane under magnification. The device provides illumination of the ear canal for observation by using an AC- or battery-powered light source and an optical magnifying system.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9 only when used in the external ear canal.

Summary

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