HD-2200 Pneumo-Dop Vascular Testing System
FDA 510(k) K894892 · Koven and Assoc., Inc.
510(k) numberK894892
Submission
- Device name
- HD-2200 Pneumo-Dop Vascular Testing System
- Applicant
- Koven and Assoc., Inc.
St. Louis, MO, US - Received
- August 1, 1989
- Decision date
- October 27, 1989
- 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
Other 510(k)s with product code DSB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260224 | MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)DSB · Traditional | ImpediMed Limited | 08/17/2026SE |
| 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 |
|---|---|---|
| K922669 | Multidop Model HD-2020 Bi-Directional Blood FlowDPW · Traditional | 01/29/1993SE |
| K920333 | Smartdop 20 Bi-Directional Blood Flow DetectorDPW · Traditional | 01/22/1993SE |
| K915550 | Mini Doppler II Ultrasound Blood Flow DetectorDPW · Traditional | 12/10/1992SE |
| K913595 | DS-240 Ambulatory Blood Pressure Monitoring SystemDXN · Traditional | 03/27/1992SE |
| K912409 | Model HD-207 Bidirectional Velocity MeterJOP · Traditional | 12/23/1991SE |
| K903026 | ES-1000SP II Smart DopDPW · Traditional | 02/26/1991SE |
| K892707 | DVM-4200 Blood FlowmeterDPW · Traditional | 07/28/1989SE |
Questions and answers
When was HD-2200 Pneumo-Dop Vascular Testing System cleared by the FDA?
HD-2200 Pneumo-Dop Vascular Testing System (K894892) received a 510(k) decision of Substantially Equivalent on October 27, 1989, 87 days after the submission was received.
What is the product code of K894892?
The FDA product code is DSB – Plethysmograph, Impedance, a Class II (moderate risk) device regulated under 21 CFR 870.2770.