Nka Model MFV-3100 & MFV-3200 Electro. Blood Flow.
FDA 510(k) K894631 · Nihon Kohden America, Inc.
510(k) numberK894631
Submission
- Device name
- Nka Model MFV-3100 & MFV-3200 Electro. Blood Flow.
- Applicant
- Nihon Kohden America, Inc.
Irvine, CA, US - Received
- July 24, 1989
- Decision date
- January 19, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2100
- Specialty
- Cardiovascular
Other 510(k)s with product code DPW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260700 | BlueDop Vascular ExpertDPW · Traditional | BlueDop Medical, Ltd. | 07/08/2026SE |
| K252810 | FloPatch FP120DPW · Special | Flosonics Medical | 04/24/2026SE |
| K251904 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock…DPW · Traditional | Remington Medical, Inc. | 11/20/2025SE |
| K251114 | FloPatch FP120DPW · Traditional | Flosonics Medical | 06/20/2025SE |
| K243852 | Elfor-LDPW · Traditional | Elfi-Tech , Ltd. | 04/14/2025SE |
| K241583 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger…DPW · Special | Remington Medical, Inc. | 08/30/2024SE |
| K223843 | FloPatch FP120DPW · Traditional | Flosonics Medical | 05/03/2023SE |
| K222242 | FloPatch FP120DPW · Traditional | Flosonics Medical | 12/09/2022SE |
| K213974 | GEM FLOW COUPLER Monitor (GEM1020M-2)DPW · Special | Synovis Micro Companies Alliance, Inc. | 04/20/2022SE |
| K211589 | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek ChargerDPW · Traditional | Remington Medical, Inc. | 01/27/2022SE |
More from Remington Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K113117 | Nihon Kohden EEG-1200A with JE-120A Multi Channel Electrode Junction BoxGWQ · Special | 03/22/2012SE |
| K120485 | Nihon Kohden QP-160 Ak Trend Program with the Addition of Dsa Asymmetry Trend and FFT POMA · Special | 03/16/2012SE |
| K092573 | Nihon Kohden QP-160AK EEG Trend ProgramOMA · Traditional | 07/09/2010SE |
| K083456 | Nihon Kohden CO2 Sensor Kit, Model TG-970PCCK · Special | 03/02/2009SE |
| K083271 | BSM-2300 &BSM6000 with CGS-9001 Series Communication Gateway, Model CGS-9001 Series…MHX · Special | 12/24/2008SE |
| K082785 | Nihon Kohden Bedside Monitor, BSM 9100A SeriesMHX · Special | 11/26/2008SE |
| K071969 | SEN-4100 Electric StimulatorGWF · Traditional | 10/06/2008SE |
| K080546 | Nihon Kohden EEG-1200A Series Neurofax, Model EEG-1200AOLT · Special | 08/29/2008SE |
| K073550 | Prefense EDNS-9000 Series Nurse Central StationMHX · Special | 03/28/2008SE |
| K080342 | Nihon Kohden Bedside Monitor, Model BSM-6000S SeriesMHX · Special | 02/26/2008SE |
Questions and answers
When was Nka Model MFV-3100 & MFV-3200 Electro. Blood Flow. cleared by the FDA?
Nka Model MFV-3100 & MFV-3200 Electro. Blood Flow. (K894631) received a 510(k) decision of Substantially Equivalent on January 19, 1990, 179 days after the submission was received.
What is the product code of K894631?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.