Cutaneous Pressure Plethysmograph
FDA 510(k) K822522 · Life Sciences Manufacturing, Inc.
510(k) numberK822522
Submission
- Device name
- Cutaneous Pressure Plethysmograph
- Applicant
- Life Sciences Manufacturing, Inc.
- Received
- August 23, 1982
- Decision date
- September 28, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSB – Plethysmograph, Impedance
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2770
- Specialty
- Cardiovascular
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| K250634 | BCM2-Body Composition MonitorDSB · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 11/24/2025SE |
| K243727 | Re:BalansDSB · Traditional | Mode Sensors AS | 10/16/2025SE |
| K250922 | Edema Guard Monitor (EGM) CardioSet-001DSB · Traditional | Cardioset Medical , Ltd. | 09/09/2025SE |
| K232089 | SOZO ProDSB · Traditional | ImpediMed Limited | 10/17/2023SE |
| K223217 | Zynex Monitoring System, Model CM-1600DSB · Traditional | Zynex Medical, Inc. | 06/16/2023SE |
| K211585 | Bodyport Cardiac ScaleDSB · Traditional | Bodyport, Inc. | 07/29/2022SE |
| K203473 | SozoDSB · Traditional | ImpediMed Limited | 04/19/2021SE |
| K193410 | SOZO Body Fluid AnalyzerDSB · Traditional | ImpediMed Limited | 10/02/2020SE |
| K191697 | Cardiac Monitor 1500DSB · Traditional | Zynex Medical, Inc. | 02/21/2020SE |
More from Zynex Medical, 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 |
| K832679 | Non-Invasive Clinical Vascular LabDQC · Traditional | 01/03/1984SE |
| K811560 | Automated Physiologic Profile MonitorDXG · Traditional | 06/18/1981SE |
Questions and answers
When was Cutaneous Pressure Plethysmograph cleared by the FDA?
Cutaneous Pressure Plethysmograph (K822522) received a 510(k) decision of Substantially Equivalent on September 28, 1982, 36 days after the submission was received.
What is the product code of K822522?
The FDA product code is DSB – Plethysmograph, Impedance, a Class II (moderate risk) device regulated under 21 CFR 870.2770.