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510(k) K091459

PHILIPS NM3 MONITOR, MODEL 7900 by Respironics Novametrix, LLC — Product Code BZK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2009
Date Received
May 18, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Monitoring (W/Wo Alarm)
Device Class
Class II
Regulation Number
868.1850
Review Panel
AN
Submission Type

Other clearances by Respironics Novametrix, LLC

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  • 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)
  • 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)
  • K030886 — NICO WITH MARS, MODEL 7300 (October 7, 2003)

Other clearances for product code BZK

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  • K180788 — Gas Module 3 (October 24, 2018)
  • K173181 — ExSpiron 1Xi (March 16, 2018)
  • K162131 — ExSpiron 1Xi (May 9, 2017)
  • K130170 — EXSPIRON 1XI (May 29, 2013)
  • K120087 — EXSPIRON (September 26, 2012)
  • K103578 — PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST (June 2, 2011)
  • K091853 — WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-01 (September 21, 2009)
  • K092217 — MERCURY VCO2 (August 21, 2009)