Periflux PF3
FDA 510(k) K890828 · Perimed, Inc.
510(k) numberK890828
Submission
- Device name
- Periflux PF3
- Applicant
- Perimed, Inc.
Piscataway, NJ, US - Received
- February 21, 1989
- Decision date
- June 20, 1989
- 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
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| 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 |
|---|---|---|
| K152930 | PeriFlux6000DPW · Traditional | 05/05/2016SE |
| K131253 | Periflux 6000LKD · Abbreviated | 10/22/2013SE |
| K120884 | Pericam PsiDPT · Traditional | 07/03/2012SE |
| K011899 | PF 5050 Pressure Unit, Model PF 5050DPW · Traditional | 11/06/2001SE |
| K990960 | Perimed Transcutaneous PO2 and PCO2 Monitor (PF5040)LKD · Traditional | 09/23/1999SE |
| K974285 | Periflux System 5000 Modular Laser Doppler System Main Unit Model PF 5001, Including PF…DPW · Traditional | 05/28/1998SE |
| K935495 | PF404/409/410/411/416/418 W/PF319:0/319:1/319:2GEX · Traditional | 04/18/1994SE |
| K932068 | Peritemp PF 4005 HeaterDPW · Traditional | 12/07/1993SE |
| K922368 | Periflux PF4001 Laser Doppler FlowmeterDPW · Traditional | 02/03/1993SE |
Questions and answers
When was Periflux PF3 cleared by the FDA?
Periflux PF3 (K890828) received a 510(k) decision of Substantially Equivalent on June 20, 1989, 119 days after the submission was received.
What is the product code of K890828?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.