QUICKAIR CHOKE RELIEVER, MODEL 59-001A

• K Number: DEN000004
• Device Name: QUICKAIR CHOKE RELIEVER, MODEL 59-001A
• Manufacturer: MAET INDUSTRIES, INC.
• Date Cleared: 2000-02-29 ( 32 days)
• Product Code: MZT
• Regulation Number: 868.5115

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

§ 868.5115 Device to relieve acute upper airway obstruction.

(a)
Identification. The device is a raised, rounded pad that, in the event of choking on a foreign body, can be applied to the abdomen and pushed upward to generate expulsion pressure to remove the obstruction to relieve acute upper airway obstruction.(b)
Classification. Class II (special controls) (“Class II Special Control Guidance Document for Acute Upper Airway Obstruction Devices”). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to § 868.9.

Summary

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