Non-Invasive Clinical Vascular Lab
FDA 510(k) K832679 · Life Sciences Manufacturing, Inc.
510(k) numberK832679
Submission
- Device name
- Non-Invasive Clinical Vascular Lab
- Applicant
- Life Sciences Manufacturing, Inc.
Mchenry, IL, US - Received
- August 9, 1983
- Decision date
- January 3, 1984
- 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 |
| 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 |
More from Intl. Acoustics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K910905 | Sfa-Ii Microprocessor-Controlled ModuleDRQ · Traditional | 07/24/1991SE |
| K903700 | Ipg-Ii ModuleDSB · Traditional | 01/16/1991SE |
| K900365 | Pag Microprocessor-Controlled ModuleDQC · Traditional | 07/18/1990SE |
| K896500 | Cwd/Ppg ModuleJOM · Traditional | 07/18/1990SE |
| K895588 | Portable Air PlethysmographDSB · Traditional | 03/27/1990SE |
| K896528 | Sfa ModuleDXG · Traditional | 01/26/1990SE |
| K884624 | Mvl/Modulab with PVR ModuleJOM · Traditional | 02/01/1989SE |
| K873041 | A-V RecorderDPT · Traditional | 02/04/1988SE |
| K822522 | Cutaneous Pressure PlethysmographDSB · Traditional | 09/28/1982SE |
| K811560 | Automated Physiologic Profile MonitorDXG · Traditional | 06/18/1981SE |
Questions and answers
When was Non-Invasive Clinical Vascular Lab cleared by the FDA?
Non-Invasive Clinical Vascular Lab (K832679) received a 510(k) decision of Substantially Equivalent on January 3, 1984, 147 days after the submission was received.
What is the product code of K832679?
The FDA product code is DQC – Phonocardiograph, a Class I (low risk) device regulated under 21 CFR 870.2390.