DELTATALKER WITH INFRARED

• K Number: K961306
• Device Name: DELTATALKER WITH INFRARED
• Manufacturer: PRENTKE ROMICH CO.
• Date Cleared: 1996-06-27 ( 84 days)
• Product Code: IQA
• Regulation Number: 890.3725
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: N/A
• Predicate For: 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

§ 890.3725 Powered environmental control system.

(a)
Identification. A powered environmental control system is an AC- or battery-powered device intended for medical purposes that is used by a patient to operate an environmental control function. Examples of environmental control functions include the following: to control room temperature, to answer a doorbell or telephone, or to sound an alarm for assistance.(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 § 890.9.