STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX

• K Number: K001306
• Device Name: STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX
• Manufacturer: ANDROMED, INC.
• Date Cleared: 2000-07-20 ( 86 days)
• Product Code: DQD
• Regulation Number: 870.1875

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

§ 870.1875 Stethoscope.

(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
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.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Summary

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