Acuson Heartsound/Pulse/Respiration Module
FDA 510(k) K900560 · Acuson Corp.
510(k) numberK900560
Submission
- Device name
- Acuson Heartsound/Pulse/Respiration Module
- Applicant
- Acuson Corp.
Mountain View, CA, US - Received
- February 7, 1990
- Decision date
- December 3, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| 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 |
| 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 |
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| K022567 | Sequoia Signature II Diagnostic Ultrasound SystemIYN · Traditional | 08/13/2002SE |
| K021497 | Cypress Ultrasound SystemIYN · Special | 07/09/2002SE |
| K010950 | Cypress SystemIYO · Abbreviated | 06/27/2001SE |
| K002807 | 3D Organ Assessment W/ Magnetic Position SensingIYO · Traditional | 12/01/2000SE |
| K992631 | Acunav Diagnostic Ultrasound CatheterDQO · Traditional | 12/15/1999SE |
| K992580 | Fetal Assessment CapIYO · Traditional | 10/18/1999SE |
| K991805 | Aspen Ultrasound with Freestyle Imaging OptionIYN · Traditional | 08/02/1999SE |
| K973767 | Harmonic Imaging with ContrastIYO · Traditional | 12/23/1997SE |
Questions and answers
When was Acuson Heartsound/Pulse/Respiration Module cleared by the FDA?
Acuson Heartsound/Pulse/Respiration Module (K900560) received a 510(k) decision of Substantially Equivalent on December 3, 1990, 299 days after the submission was received.
What is the product code of K900560?
The FDA product code is DQC – Phonocardiograph, a Class I (low risk) device regulated under 21 CFR 870.2390.