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510(k) K900696

BIORE CP-100 CARDIOPULMONARY MONITOR by Bicore Monitoring Systems — Product Code BZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1990
Date Received
February 13, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Pulmonary Function Data
Device Class
Class II
Regulation Number
868.1880
Review Panel
AN
Submission Type

Other clearances by Bicore Monitoring Systems

  • K935788 — BICORE SMARTCATH INTRATRACHEAL CATHETER (July 3, 1995)
  • K921717 — BICORE SMARTVALVE OCCLUSION VALVE (November 6, 1992)
  • K896718 — BICORE VARIFLEX(R) FLOW TRANSDUCER (February 22, 1990)

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  • K181524 — Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable (November 30, 2018)
  • K162515 — COSMED K5 Wearable Metabolic Technology (June 20, 2017)
  • K161295 — MiniBox + (October 21, 2016)
  • K150810 — Vyntus / SentrySuite Product Line (August 14, 2015)
  • K133925 — VYNTUS/ SENTRYSUITE PRODUCT LINE (August 22, 2014)
  • K133051 — PULMONE MINIBOX PFT TM (May 2, 2014)
  • K102047 — LCI OPTION FOR INNOCOR (November 1, 2011)