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510(k) K152930

PeriFlux6000 by Perimed AB — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2016
Date Received
October 5, 2015
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

  • K131253 — PERIFLUX 6000 (October 22, 2013)
  • K120884 — PERICAM PSI (July 3, 2012)
  • K011899 — PF 5050 PRESSURE UNIT, MODEL PF 5050 (November 6, 2001)
  • 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)

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