TI500 GLOBE-TROTTER TRANSPORT SYSTEM

• K Number: K001019
• Device Name: TI500 GLOBE-TROTTER TRANSPORT SYSTEM
• Manufacturer: HILL-ROM AIR-SHIELDS
• Date Cleared: 2000-04-27 ( 28 days)
• Product Code: FPL
• Regulation Number: 880.5410

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

§ 880.5410 Neonatal transport incubator.

(a)
Identification. A neonatal transport incubator is a device consisting of a portable rigid boxlike enclosure with insulated walls in which an infant may be kept in a controlled environment while being transported for medical care. The device may include straps to secure the infant, a battery-operated heater, an AC-powered battery charger, a fan to circulate the warmed air, a container for water to add humidity, and provision for a portable oxygen bottle.(b)
Classification. Class II (performance standards).

Summary

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