Rayden Medical Mini Pulse Volume Record
FDA 510(k) K833155 · Burditt & Calkins-Siemens-Elema
510(k) numberK833155
Submission
- Device name
- Rayden Medical Mini Pulse Volume Record
- Applicant
- Burditt & Calkins-Siemens-Elema
Walker, MI, US - Received
- September 15, 1983
- Decision date
- January 26, 1984
- 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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| K191697 | Cardiac Monitor 1500DSB · Traditional | Zynex Medical, Inc. | 02/21/2020SE |
More from Zynex Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K833519 | Pulse Generator Model 688DXY · Traditional | 01/30/1984SE |
| K830344 | Siemens-Elma Pulse Generator #718DXY · Traditional | 05/27/1983SE |
| K823435 | Mon-A-Therm Myocardial Temp. SensorKRB · Traditional | 12/30/1982SE |
| K823591 | Ameda Hand Breast PumpHGY · Traditional | 12/28/1982SE |
| K822239 | Coaxial Bipolar Pacing ElectrodeDTB · Traditional | 10/04/1982SE |
| K821712 | Informed Remote Field Unit Model IFM1000BTY · Traditional | 07/26/1982SE |
| K803111 | ErectaidFAE · Traditional | 01/23/1981SE |
| K802607 | Terperatur Sensing DeviceFLL · Traditional | 11/19/1980SE |
| K760787 | Liberator/StrollerBYJ · Traditional | 10/22/1976SE |
Questions and answers
When was Rayden Medical Mini Pulse Volume Record cleared by the FDA?
Rayden Medical Mini Pulse Volume Record (K833155) received a 510(k) decision of Substantially Equivalent on January 26, 1984, 133 days after the submission was received.
What is the product code of K833155?
The FDA product code is DSB – Plethysmograph, Impedance, a Class II (moderate risk) device regulated under 21 CFR 870.2770.