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510(k) K041450

MODIFICATION TO NICO WITH MARS, MODEL 7300 by Respironics Novametrix, Inc. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2004
Date Received
June 1, 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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