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510(k) K103578

PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST by Respironics Novametrix, LLC — Product Code BZK

K103578 is an FDA 510(k) premarket notification submitted by Respironics Novametrix, LLC for the device "PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST". The FDA issued a decision of Substantially Equivalent on June 2, 2011. The device falls under product code BZK (Spirometer, Monitoring (W/Wo Alarm)), a Class II device regulated under 21 CFR 868.1850. Respironics Novametrix, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2011
Date Received
December 6, 2010
Clearance Type
Traditional
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

  • K092217 — MERCURY VCO2 (August 21, 2009)
  • 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)
  • 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

  • K192584 — BEACON Caresystem Model 00002144 (December 18, 2019)
  • K192595 — ExSpiron 2Xi (December 17, 2019)
  • 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)
  • K091853 — WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-01 (September 21, 2009)
  • K092217 — MERCURY VCO2 (August 21, 2009)
  • K091459 — PHILIPS NM3 MONITOR, MODEL 7900 (July 28, 2009)

FDA data resources