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510(k) K010795

CAPNOPROBE SL, MODEL 2000 by Optical Sensors, Inc. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2001
Date Received
March 16, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type

Other clearances by Optical Sensors, Inc.

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  • K963935 — OLYMPUS CRITICAL CARE MONITORING SYSTEM (January 23, 1997)
  • K951094 — POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM (January 16, 1996)
  • K931185 — SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE (October 21, 1993)

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