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510(k) K932098

CAPNOMAC ULTIMA ANESTHESIA MONITOR by Datex Division Instrumentarium Corp. — Product Code BZK

K932098 is an FDA 510(k) premarket notification submitted by Datex Division Instrumentarium Corp. for the device "CAPNOMAC ULTIMA ANESTHESIA MONITOR". The FDA issued a decision of Substantially Equivalent on November 29, 1993. The device falls under product code BZK (Spirometer, Monitoring (W/Wo Alarm)), a Class II device regulated under 21 CFR 868.1850. Datex Division Instrumentarium Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1993
Date Received
May 3, 1993
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 Datex Division Instrumentarium Corp.

  • K953175 — AS/3 ESTPR MODULE (February 6, 1997)
  • K961247 — AS/3 LIGHT MONITOR (October 23, 1996)
  • K943458 — AS/3 AIRWAY MODULE (February 14, 1995)
  • K945234 — AS/3 MEMORY MODULE, M0MEM (January 27, 1995)
  • K933156 — DATEX AS/3 PATIENT MONITOR (December 30, 1994)
  • K933285 — DATEX AS/3 TM ANAESTHESIA MONITOR (November 14, 1994)
  • K943456 — AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT (October 17, 1994)
  • K923172 — ANAESTHESIA RECORD KEEPER (August 9, 1994)
  • K935477 — AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD (August 1, 1994)
  • K943457 — AS/3 PRESSURE TEMPERATURE MODULE, M-PT (July 27, 1994)

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