Phonocardiograph
FDA product code DQC · Class I (low risk) · 21 CFR 870.2390 · Cardiovascular
18510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Intl. Acoustics, Inc. 3
- Honeywell, Inc. 2
- Life Sciences Manufacturing, Inc. 2
- Hewlett-Packard Co. 1
- Burdick Corp. 1
- Nicolet Biomedical Instruments 1
- Edwards Laboratories 1
- Andries Tek, Inc. 1
- Acuson Corp. 1
- Reeves Scientific, Inc. 1
- Echo Ultrasound 1
- Technology Applications Assoc., Inc. 1
- Flowscan, Inc. 1
- Cardiophonics, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950537 | Cardiophonics Incorporated DPS 2000 PhonocardiographDQC · Traditional | Cardiophonics, Inc. | 03/01/1996SE |
| K952651 | Life Sound SensorDQC · Traditional | Flowscan, Inc. | 09/19/1995SE |
| K943726 | Acoustic RecorderDQC · Traditional | Technology Applications Assoc., Inc. | 11/30/1994SE |
| K924054 | PhonocardiographDQC · Traditional | Echo Ultrasound | 01/22/1993SE |
| K902185 | Dynamic Spectral PhonocardiographDQC · Traditional | Reeves Scientific, Inc. | 03/25/1991SE |
| K900560 | Acuson Heartsound/Pulse/Respiration ModuleDQC · Traditional | Acuson Corp. | 12/03/1990SE |
| K900365 | Pag Microprocessor-Controlled ModuleDQC · Traditional | Life Sciences Manufacturing, Inc. | 07/18/1990SE |
| K873640 | Modified DSP100 AmplifierDQC · Traditional | Intl. Acoustics, Inc. | 12/07/1987SE |
| K870545 | Andries Physical Assessment ComputerDQC · Traditional | Andries Tek, Inc. | 08/14/1987SE |
| K864429 | DSP100 Carotid Phonoangiography ModuleDQC · Traditional | Intl. Acoustics, Inc. | 05/12/1987SE |
| K860814 | DSP100 AmplifierDQC · Traditional | Intl. Acoustics, Inc. | 12/05/1986SE |
| K832679 | Non-Invasive Clinical Vascular LabDQC · Traditional | Life Sciences Manufacturing, Inc. | 01/03/1984SE |
| K811626 | Meddars/Ultra Imager Pulse/Phon ModuleDQC · Traditional | Honeywell, Inc. | 07/01/1981SE |
| K800655 | Model 100 SpectraviewDQC · Traditional | Edwards Laboratories | 04/16/1980SE |
| K792466 | NIC-200 Ventricular Function AnalyzerDQC · Traditional | Nicolet Biomedical Instruments | 01/24/1980SE |
| K780116 | Amplifier, PC-700DQC · Traditional | Burdick Corp. | 02/24/1978SE |
| K770757 | Pulse/Phonocardiography Channel, 144DQC · Traditional | Honeywell, Inc. | 05/09/1977SE |
| K760464 | Phon/Stress System (#21126A)DQC · Traditional | Hewlett-Packard Co. | 08/30/1976SE |