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510(k) K932068

PERITEMP PF 4005 HEATER by Perimed, Inc. — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1993
Date Received
April 29, 1993
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, Inc.

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  • 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)
  • K922368 — PERIFLUX PF4001 LASER DOPPLER FLOWMETER (February 3, 1993)
  • K890828 — PERIFLUX PF3 (June 20, 1989)

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