Product code DQC
- Device name
- Phonocardiograph
- Medical specialty
- Cardiovascular
- Device class
- 1
- Regulation number
- 870.2390
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K950537 | CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH | Cardiophonics, Inc. | 1996-03-01 |
| K952651 | LIFE SOUND SENSOR | Flowscan, Inc. | 1995-09-19 |
| K943726 | ACOUSTIC RECORDER | Technology Applications Assoc., Inc. | 1994-11-30 |
| K924054 | PHONOCARDIOGRAPH | Echo Ultrasound | 1993-01-22 |
| K902185 | DYNAMIC SPECTRAL PHONOCARDIOGRAPH | Reeves Scientific, Inc. | 1991-03-25 |
| K900560 | ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE | Acuson Corp. | 1990-12-03 |
| K900365 | PAG MICROPROCESSOR-CONTROLLED MODULE | Life Sciences Manufacturing, Inc. | 1990-07-18 |
| K873640 | MODIFIED DSP100 AMPLIFIER | Intl. Acoustics, Inc. | 1987-12-07 |
| K870545 | ANDRIES PHYSICAL ASSESSMENT COMPUTER | Andries Tek, Inc. | 1987-08-14 |
| K864429 | DSP100 CAROTID PHONOANGIOGRAPHY MODULE | Intl. Acoustics, Inc. | 1987-05-12 |
| K860814 | DSP100 AMPLIFIER | Intl. Acoustics, Inc. | 1986-12-05 |
| K811626 | MEDDARS/ULTRA IMAGER PULSE/PHON MODULE | Honeywell, Inc. | 1981-07-01 |
| K800655 | MODEL 100 SPECTRAVIEW | Edwards Laboratories | 1980-04-16 |
| K792466 | NIC-200 VENTRICULAR FUNCTION ANALYZER | Nicolet Biomedical Instruments | 1980-01-24 |
| K780116 | AMPLIFIER, PC-700 | Burdick Corp. | 1978-02-24 |
| K770757 | PULSE/PHONOCARDIOGRAPHY CHANNEL, 144 | Honeywell, Inc. | 1977-05-09 |
| K760464 | PHON/STRESS SYSTEM (#21126A) | Hewlett-Packard Co. | 1976-08-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810209880040 | EFAST (Eko Foundation Analysis Software with Transformers) | Eko Devices, Inc. | 2026-01-29 |
| 00850010298184 | EMAS (Eko Murmur Analysis Software) | Eko Devices, Inc. | 2025-03-17 |
| B596HT101Y2 | HemoTag | Aventusoft L.L.C. | 2024-01-29 |
| 09351356000031 | Stethee Pro Mobile Android Application | M3DICINE PTY LTD | 2020-12-23 |
| 09351356000048 | Stethee Pro Mobile iOS Application | M3DICINE PTY LTD | 2020-12-23 |
| 09351356000055 | Stethee Pro Central Web Application | M3DICINE PTY LTD | 2020-12-23 |
| 00707387779054 | 3M™ Littmann® | 3M COMPANY | 2018-09-24 |