CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH

• K Number: K950537
• Device Name: CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH
• Manufacturer: CARDIOPHONICS, INC.
• Date Cleared: 1996-03-01 ( 388 days)
• Product Code: DQC
• Regulation Number: 870.2390
• Type: Traditional
• Panel: Cardiovascular
• 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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Summary

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Regulation Number and Section

§ 870.2390 Phonocardiograph.

(a)
Identification. A phonocardiograph is a device used to amplify or condition the signal from a heart sound transducer. This device furnishes the excitation energy for the transducer and provides a visual or audible display of the heart sounds.(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 § 870.9.