DURA-BOARD ARMBOARD

• K Number: K964273
• Device Name: DURA-BOARD ARMBOARD
• Manufacturer: ALLEN MEDICAL SYSTEMS, INC.
• Date Cleared: 1997-01-08 ( 72 days)
• Product Code: GDC , FQO , FWW
• Regulation Number: 878.4960
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: 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

§ 878.4960 Operating tables and accessories and operating chairs and accessories.

(a)
Identification. Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.(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 § 878.9.