SHADOW MEDAL LOCATOR

• K Number: K953277
• Device Name: SHADOW MEDAL LOCATOR
• Manufacturer: FATSWITH INTL., INC.
• Date Cleared: 1996-04-01 ( 263 days)
• Product Code: HPM
• Regulation Number: 886.4400
• Type: Traditional
• Panel: Ophthalmic
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 886.4400 Electronic metal locator.

(a)
Identification. An electronic metal locator is an AC-powered device with probes intended to locate metallic foreign bodies in the eye or eye socket.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.