RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S

• K Number: K001030
• Device Name: RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S
• Manufacturer: DYMEDIX, INC.
• Date Cleared: 2000-05-11 ( 42 days)
• Product Code: BZQ
• Regulation Number: 868.2375
• Type: Abbreviated
• Panel: Anesthesiology
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: K040605

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

§ 868.2375 Breathing frequency monitor.

(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).