Cwd/Ppg Module
FDA 510(k) K896500 · Life Sciences Manufacturing, Inc.
510(k) numberK896500
Submission
- Device name
- Cwd/Ppg Module
- Applicant
- Life Sciences Manufacturing, Inc.
West Lebanon, NH, US - Received
- November 14, 1989
- Decision date
- July 18, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JOM – Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2780
- Specialty
- Cardiovascular
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More from Bauerfeind AG
| 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 |
| 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 |
| K832679 | Non-Invasive Clinical Vascular LabDQC · Traditional | 01/03/1984SE |
| K822522 | Cutaneous Pressure PlethysmographDSB · Traditional | 09/28/1982SE |
| K811560 | Automated Physiologic Profile MonitorDXG · Traditional | 06/18/1981SE |
Questions and answers
When was Cwd/Ppg Module cleared by the FDA?
Cwd/Ppg Module (K896500) received a 510(k) decision of Substantially Equivalent on July 18, 1990, 246 days after the submission was received.
What is the product code of K896500?
The FDA product code is JOM – Plethysmograph, Photoelectric, Pneumatic Or Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 870.2780.