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510(k) K030886

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2003
Date Received
March 21, 2003
Clearance Type
Traditional
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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  • K032949 — SPOT CHECK PULSE OXIMETER,512/513 (August 23, 2004)
  • K041450 — MODIFICATION TO NICO WITH MARS, MODEL 7300 (June 18, 2004)
  • K032755 — MODEL 509M PULSE OXIMETER, MODEL 509M (May 21, 2004)

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