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510(k) K042601

CAPNOSTAT 5 by Respironics Novametrix, Inc. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2004
Date Received
September 24, 2004
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

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  • K032755 — MODEL 509M PULSE OXIMETER, MODEL 509M (May 21, 2004)
  • K030886 — NICO WITH MARS, MODEL 7300 (October 7, 2003)

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