DQC · Phonocardiograph
Cardiovascular · 21 CFR 870.2390 · Class 1
Overview
| Product Code | DQC |
|---|---|
| Device Name | Phonocardiograph |
| Regulation | 21 CFR 870.2390 |
| Device Class | Class 1 |
| Review Panel | Cardiovascular |
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.
Classification Rationale
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.
Recent Cleared Devices (18 of 18)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K950537 | CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH | Cardiophonics, Inc. | Mar 1, 1996 | SESE |
| K952651 | LIFE SOUND SENSOR | Flowscan, Inc. | Sep 19, 1995 | SESE |
| K943726 | ACOUSTIC RECORDER | Technology Applications Assoc., Inc. | Nov 30, 1994 | SESE |
| K924054 | PHONOCARDIOGRAPH | Echo Ultrasound | Jan 22, 1993 | SESE |
| K902185 | DYNAMIC SPECTRAL PHONOCARDIOGRAPH | Reeves Scientific, Inc. | Mar 25, 1991 | SESE |
| K900560 | ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE | Acuson Corp. | Dec 3, 1990 | SESE |
| K900365 | PAG MICROPROCESSOR-CONTROLLED MODULE | Life Sciences Manufacturing, Inc. | Jul 18, 1990 | SESE |
| K873640 | MODIFIED DSP100 AMPLIFIER | Intl. Acoustics, Inc. | Dec 7, 1987 | SESE |
| K870545 | ANDRIES PHYSICAL ASSESSMENT COMPUTER | Andries Tek, Inc. | Aug 14, 1987 | SESE |
| K864429 | DSP100 CAROTID PHONOANGIOGRAPHY MODULE | Intl. Acoustics, Inc. | May 12, 1987 | SESE |
| K860814 | DSP100 AMPLIFIER | Intl. Acoustics, Inc. | Dec 5, 1986 | SESE |
| K832679 | NON-INVASIVE CLINICAL VASCULAR LAB | Life Sciences Manufacturing, Inc. | Jan 3, 1984 | SESE |
| K811626 | MEDDARS/ULTRA IMAGER PULSE/PHON MODULE | Honeywell, Inc. | Jul 1, 1981 | SESE |
| K800655 | MODEL 100 SPECTRAVIEW | Edwards Laboratories | Apr 16, 1980 | SESE |
| K792466 | NIC-200 VENTRICULAR FUNCTION ANALYZER | Nicolet Biomedical Instruments | Jan 24, 1980 | SESE |
| K780116 | AMPLIFIER, PC-700 | Burdick Corp. | Feb 24, 1978 | SESE |
| K770757 | PULSE/PHONOCARDIOGRAPHY CHANNEL, 144 | Honeywell, Inc. | May 9, 1977 | SESE |
| K760464 | PHON/STRESS SYSTEM (#21126A) | Hewlett-Packard Co. | Aug 30, 1976 | SESE |
Top Applicants
- Intl. Acoustics, Inc. — 3 clearances
- Honeywell, Inc. — 2 clearances
- Life Sciences Manufacturing, Inc. — 2 clearances
- Acuson Corp. — 1 clearance
- Andries Tek, Inc. — 1 clearance
