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510(k) K921717

BICORE SMARTVALVE OCCLUSION VALVE by Bicore Monitoring Systems — Product Code BZK

K921717 is an FDA 510(k) premarket notification submitted by Bicore Monitoring Systems for the device "BICORE SMARTVALVE OCCLUSION VALVE". The FDA issued a decision of Substantially Equivalent on November 6, 1992. The device falls under product code BZK (Spirometer, Monitoring (W/Wo Alarm)), a Class II device regulated under 21 CFR 868.1850. Bicore Monitoring Systems has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1992
Date Received
April 9, 1992
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 Bicore Monitoring Systems

  • K935788 — BICORE SMARTCATH INTRATRACHEAL CATHETER (July 3, 1995)
  • K900696 — BIORE CP-100 CARDIOPULMONARY MONITOR (November 29, 1990)
  • K896718 — BICORE VARIFLEX(R) FLOW TRANSDUCER (February 22, 1990)

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