ADULT-PEDIATRIC TRANSPORT SYSTEM

• K Number: K955766
• Device Name: ADULT-PEDIATRIC TRANSPORT SYSTEM
• Manufacturer: INTERNATIONAL BIOMEDICAL, INC.
• Date Cleared: 1996-08-07 ( 231 days)
• Product Code: FPO
• Regulation Number: 880.6910

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

§ 880.6910 Wheeled stretcher.

(a)
Identification. A wheeled stretcher is a device consisting of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device may have side rails, supports for fluid infusion equipment, and patient securement straps. The frame may be fixed or collapsible for use in an ambulance.(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 § 880.9.

Summary

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