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510(k) K080652

MERCURY VCO2 MODULE WITH CAPNOSTAT 5 by Respironics Novametrix, LLC — Product Code BZK

K080652 is an FDA 510(k) premarket notification submitted by Respironics Novametrix, LLC for the device "MERCURY VCO2 MODULE WITH CAPNOSTAT 5". The FDA issued a decision of Substantially Equivalent on June 20, 2008. 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 20, 2008
Date Received
March 7, 2008
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

  • K103578 — PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST (June 2, 2011)
  • K092217 — MERCURY VCO2 (August 21, 2009)
  • K091459 — PHILIPS NM3 MONITOR, MODEL 7900 (July 28, 2009)
  • 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)
  • 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)

FDA data resources