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510(k) K011861

BERNOULLI VENTILATOR MANAGEMENT SYSTEM by Cardiopulmonary Corp. — Product Code MOD

K011861 is an FDA 510(k) premarket notification submitted by Cardiopulmonary Corp. for the device "BERNOULLI VENTILATOR MANAGEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on November 6, 2001. The device falls under product code MOD (Accessory To Continuous Ventilator (Respirator)), a Class II device regulated under 21 CFR 868.5895. Cardiopulmonary Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2001
Date Received
June 14, 2001
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)
  • K091461 — BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE (August 14, 2009)
  • 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)
  • 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

  • K260051 — CorVision® (91-205-Z0014) (May 12, 2026)
  • K242485 — EveryWare (May 20, 2025)
  • K161411 — Care Cycle Connect Application (February 17, 2017)
  • 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)
  • K963633 — VENTNET; CENTRAL MONITORING STATION (December 16, 1996)

FDA data resources