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510(k) K032291

TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM by Linde Medical Sensors AG — Product Code DOA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2004
Date Received
July 24, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.
Device Class
Class II
Regulation Number
862.3320
Review Panel
TX
Submission Type

Other clearances by Linde Medical Sensors AG

  • K043357 — TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 (March 4, 2005)
  • K003943 — MICROGAS 7650 TRANSCUTANEOUS MONITOR (May 4, 2001)
  • K991644 — MICROGAS 7650 TRANSCUTANEOUS MONITOR (May 21, 1999)