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510(k) K130208

BERNOULLI ENTERPRISE SOFTWARE by Cardiopulmonary Corp. — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2013
Date Received
January 28, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Cardiopulmonary Corp.

  • 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)
  • 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)

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