Product Code: DQC FDA class 1 21 CFR 870.2390

Phonocardiograph

Cardiovascular

The Phonocardiograph is a cardiovascular diagnostic instrument used to record heart sounds and murmurs as a graphical waveform, aiding clinicians in the assessment of cardiac function and valvular conditions. It is classified as an FDA Class 1 device, representing the lowest level of regulatory concern, and is subject to general controls only. The product code is DQC and it is regulated under 21 CFR 870.2390 within the Cardiovascular medical specialty.

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510(k)s

FEI Numbers

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Unique Applicants

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Basic Information

Product Code: DQC
Device Class: FDA class 1
Regulation Number: 870.2390
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 18 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K950537	CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH	Mar 01, 1996	Substantially Equivalent	Cardiophonics, Inc.
K952651	LIFE SOUND SENSOR	Sep 19, 1995	Substantially Equivalent	Flowscan, Inc.
K943726	ACOUSTIC RECORDER	Nov 30, 1994	Substantially Equivalent	Technology Applications Assoc., Inc.
K924054	PHONOCARDIOGRAPH	Jan 22, 1993	Substantially Equivalent	Echo Ultrasound
K902185	DYNAMIC SPECTRAL PHONOCARDIOGRAPH	Mar 25, 1991	Substantially Equivalent	Reeves Scientific, Inc.
K900560	ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE	Dec 03, 1990	Substantially Equivalent	Acuson Corp.
K900365	PAG MICROPROCESSOR-CONTROLLED MODULE	Jul 18, 1990	Substantially Equivalent	Life Sciences Manufacturing, Inc.
K873640	MODIFIED DSP100 AMPLIFIER	Dec 07, 1987	Substantially Equivalent	Intl. Acoustics, Inc.
K870545	ANDRIES PHYSICAL ASSESSMENT COMPUTER	Aug 14, 1987	Substantially Equivalent	Andries Tek, Inc.
K864429	DSP100 CAROTID PHONOANGIOGRAPHY MODULE	May 12, 1987	Substantially Equivalent	Intl. Acoustics, Inc.
K860814	DSP100 AMPLIFIER	Dec 05, 1986	Substantially Equivalent	Intl. Acoustics, Inc.
K832679	NON-INVASIVE CLINICAL VASCULAR LAB	Jan 03, 1984	Substantially Equivalent	Life Sciences Manufacturing, Inc.
K811626	MEDDARS/ULTRA IMAGER PULSE/PHON MODULE	Jul 01, 1981	Substantially Equivalent	Honeywell, Inc.
K800655	MODEL 100 SPECTRAVIEW	Apr 16, 1980	Substantially Equivalent	Edwards Laboratories
K792466	NIC-200 VENTRICULAR FUNCTION ANALYZER	Jan 24, 1980	Substantially Equivalent	Nicolet Biomedical Instruments
K780116	AMPLIFIER, PC-700	Feb 24, 1978	Substantially Equivalent	Burdick Corp.
K770757	PULSE/PHONOCARDIOGRAPHY CHANNEL, 144	May 09, 1977	Substantially Equivalent	Honeywell, Inc.
K760464	PHON/STRESS SYSTEM (#21126A)	Aug 30, 1976	Substantially Equivalent	Hewlett-Packard Co.