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510(k) K131253

PERIFLUX 6000 by Perimed AB — Product Code LKD

K131253 is an FDA 510(k) premarket notification submitted by Perimed AB for the device "PERIFLUX 6000". The FDA issued a decision of Substantially Equivalent on October 22, 2013. The device falls under product code LKD (Monitor, Carbon-Dioxide, Cutaneous), a Class II device regulated under 21 CFR 868.2480. Perimed AB has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2013
Date Received
May 2, 2013
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Carbon-Dioxide, Cutaneous
Device Class
Class II
Regulation Number
868.2480
Review Panel
AN
Submission Type

Other clearances by Perimed AB

  • K152930 — PeriFlux6000 (May 5, 2016)
  • 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)

Other clearances for product code LKD

  • K232516 — Sentec Digital Monitoring System (SDMS) tCOM+ (May 17, 2024)
  • K151329 — SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V- (December 17, 2015)
  • K110474 — PHILIPS INTELLIVUE TCG10 (September 30, 2011)
  • K101690 — SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR AD (December 3, 2010)
  • K093154 — TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM (February 5, 2010)
  • K043357 — TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 (March 4, 2005)
  • K043003 — TCM40 MONITORING SYSTEM (March 1, 2005)
  • K041548 — SENTEC DIGITAL MONITOR MODEL #SDM (August 9, 2004)
  • K990960 — PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) (September 23, 1999)
  • K980756 — COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE (November 5, 1998)

FDA data resources