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510(k) K120884

PERICAM PSI by Perimed AB — Product Code DPT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2012
Date Received
March 23, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Blood-Flow, Extravascular
Device Class
Class II
Regulation Number
870.2120
Review Panel
CV
Submission Type

Other clearances by Perimed AB

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  • K131253 — PERIFLUX 6000 (October 22, 2013)
  • 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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