RETRACTOR ARM CLAMP

• K Number: K960019
• Device Name: RETRACTOR ARM CLAMP
• Manufacturer: BIOPSYS MEDICAL, INC.
• Date Cleared: 1996-02-09 ( 38 days)
• Product Code: FWZ
• Regulation Number: 878.4950

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

§ 878.4950 Manual operating table and accessories and manual operating chair and accessories.

(a)
Identification. A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.(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 § 878.9.

Summary

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