HEAT & MOISTURE EXCHANGER

• K Number: K955008
• Device Name: HEAT & MOISTURE EXCHANGER
• Manufacturer: INTERTECH RESOURCES, INC.
• Date Cleared: 1996-01-30 ( 90 days)
• Product Code: BYD
• Regulation Number: 868.5375

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

§ 868.5375 Heat and moisture condenser (artificial nose).

(a)
Identification. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by 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 the limitations in § 868.9.

Summary

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