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510(k) K032949

SPOT CHECK PULSE OXIMETER,512/513 by Respironics Novametrix, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2004
Date Received
September 22, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

Other clearances by Respironics Novametrix, Inc.

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  • K091459 — PHILIPS NM3 MONITOR, MODEL 7900 (July 28, 2009)
  • K080652 — MERCURY VCO2 MODULE WITH CAPNOSTAT 5 (June 20, 2008)
  • K053174 — LOFLO C5 CO2 SENSOR (January 12, 2006)
  • K042601 — CAPNOSTAT 5 (November 19, 2004)
  • K032971 — TIDAL WAVE SP MODEL 710/715 AND 715 (August 26, 2004)
  • K041450 — MODIFICATION TO NICO WITH MARS, MODEL 7300 (June 18, 2004)
  • K032755 — MODEL 509M PULSE OXIMETER, MODEL 509M (May 21, 2004)
  • K030886 — NICO WITH MARS, MODEL 7300 (October 7, 2003)

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