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510(k) K935788

BICORE SMARTCATH INTRATRACHEAL CATHETER by Bicore Monitoring Systems — Product Code MOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1995
Date Received
December 6, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory To Continuous Ventilator (Respirator)
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

Other clearances by Bicore Monitoring Systems

  • K921717 — BICORE SMARTVALVE OCCLUSION VALVE (November 6, 1992)
  • K900696 — BIORE CP-100 CARDIOPULMONARY MONITOR (November 29, 1990)
  • K896718 — BICORE VARIFLEX(R) FLOW TRANSDUCER (February 22, 1990)

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  • K091461 — BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE (August 14, 2009)
  • K052751 — VENTLINK SYSTEM (December 23, 2005)
  • K052244 — IISIS, VERSION 1.0 (October 13, 2005)
  • K040712 — AIR SAFETY HEPA, MODEL 3500 (June 3, 2004)
  • K022062 — IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 (May 6, 2003)
  • K010401 — TRI-PLEX ADAPTER (October 30, 2002)
  • K011861 — BERNOULLI VENTILATOR MANAGEMENT SYSTEM (November 6, 2001)
  • K963633 — VENTNET; CENTRAL MONITORING STATION (December 16, 1996)