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510(k) K890932

CAV 3.0C SOFTWARE PROGRAM by Siemens Life Support Systems — Product Code BZK

K890932 is an FDA 510(k) premarket notification submitted by Siemens Life Support Systems for the device "CAV 3.0C SOFTWARE PROGRAM". The FDA issued a decision of Substantially Equivalent on June 12, 1989. The device falls under product code BZK (Spirometer, Monitoring (W/Wo Alarm)), a Class II device regulated under 21 CFR 868.1850. Siemens Life Support Systems has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1989
Date Received
February 24, 1989
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 Siemens Life Support Systems

  • K902859 — SERVO VENTILATOR 300 (April 26, 1991)
  • K903991 — PCM ANESTHESIA (February 25, 1991)
  • K901474 — ANESTHESIA WORKSTATION (April 10, 1990)
  • K893786 — SERVO ANESTHESIA CIRCLE 985 (September 22, 1989)
  • K890921 — DATA EXCHANGE SYSTEM, MODEL 24 (June 8, 1989)

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