Home / 510(k) Clearances / K011899

510(k) K011899

PF 5050 PRESSURE UNIT, MODEL PF 5050 by Perimed AB — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2001
Date Received
June 18, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Blood, Cardiovascular
Device Class
Class II
Regulation Number
870.2100
Review Panel
CV
Submission Type

Other clearances by Perimed AB

  • K152930 — PeriFlux6000 (May 5, 2016)
  • K131253 — PERIFLUX 6000 (October 22, 2013)
  • K120884 — PERICAM PSI (July 3, 2012)
  • K990960 — PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) (September 23, 1999)
  • K974285 — PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLU (May 28, 1998)
  • K935495 — PF404/409/410/411/416/418 W/PF319:0/319:1/319:2 (April 18, 1994)
  • K932068 — PERITEMP PF 4005 HEATER (December 7, 1993)
  • K922368 — PERIFLUX PF4001 LASER DOPPLER FLOWMETER (February 3, 1993)
  • K890828 — PERIFLUX PF3 (June 20, 1989)

Other clearances for product code DPW

  • K251904 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speake (November 20, 2025)
  • K251114 — FloPatch FP120 (June 20, 2025)
  • K243852 — Elfor-L (April 14, 2025)
  • K241583 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charge (August 30, 2024)
  • K223843 — FloPatch FP120 (May 3, 2023)
  • K222242 — FloPatch FP120 (December 9, 2022)
  • K213974 — GEM FLOW COUPLER Monitor (GEM1020M-2) (April 20, 2022)
  • K211589 — VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charge (January 27, 2022)
  • K212065 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charge (October 7, 2021)
  • K201114 — Bidop 7 (January 5, 2021)