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510(k) K990960

PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) by Perimed, Inc. — Product Code LKD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1999
Date Received
March 22, 1999
Clearance Type
Traditional
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, Inc.

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  • K011899 — PF 5050 PRESSURE UNIT, MODEL PF 5050 (November 6, 2001)
  • 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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  • K980756 — COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE (November 5, 1998)