Cardiophonics Incorporated DPS 2000 Phonocardiograph
FDA 510(k) K950537 · Cardiophonics, Inc.
510(k) numberK950537
Submission
- Device name
- Cardiophonics Incorporated DPS 2000 Phonocardiograph
- Applicant
- Cardiophonics, Inc.
Port Jefferson Station, NY, US - Received
- February 7, 1995
- Decision date
- March 1, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DQC – Phonocardiograph
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.2390
- Specialty
- Cardiovascular
Other 510(k)s with product code DQC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
Questions and answers
When was Cardiophonics Incorporated DPS 2000 Phonocardiograph cleared by the FDA?
Cardiophonics Incorporated DPS 2000 Phonocardiograph (K950537) received a 510(k) decision of Substantially Equivalent on March 1, 1996, 388 days after the submission was received.
What is the product code of K950537?
The FDA product code is DQC – Phonocardiograph, a Class I (low risk) device regulated under 21 CFR 870.2390.