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510(k) K091461

BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE by Cardiopulmonary Corp. — Product Code MOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2009
Date Received
May 18, 2009
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 Cardiopulmonary Corp.

  • K130208 — BERNOULLI ENTERPRISE SOFTWARE (December 20, 2013)
  • K061932 — BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE (September 14, 2006)
  • K051283 — MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE (June 23, 2005)
  • K020018 — MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE (February 21, 2002)
  • K011861 — BERNOULLI VENTILATOR MANAGEMENT SYSTEM (November 6, 2001)
  • K990429 — MODIFICATION OF VENTURI VENTILATOR (February 24, 1999)
  • K982174 — VENTURI VENTILATOR (June 24, 1998)
  • K943412 — VENTURI VENTILATOR (October 16, 1995)

Other clearances for product code MOD

  • K242485 — EveryWare (May 20, 2025)
  • K161411 — Care Cycle Connect Application (February 17, 2017)
  • 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)
  • K935788 — BICORE SMARTCATH INTRATRACHEAL CATHETER (July 3, 1995)