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510(k) K043357

TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 by Linde Medical Sensors AG — Product Code LKD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2005
Date Received
December 6, 2004
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 Linde Medical Sensors AG

  • K032291 — TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM (August 24, 2004)
  • K003943 — MICROGAS 7650 TRANSCUTANEOUS MONITOR (May 4, 2001)
  • K991644 — MICROGAS 7650 TRANSCUTANEOUS MONITOR (May 21, 1999)

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  • K990960 — PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) (September 23, 1999)
  • K980756 — COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE (November 5, 1998)