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510(k) K110083

V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE by Respironics California, Inc. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2012
Date Received
January 11, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

Other clearances by Respironics California, Inc.

  • K110795 — V200 INTELLI-TRAK OPTION (August 19, 2011)
  • K102054 — V200 VENTILATOR (December 22, 2010)
  • K082660 — V60 VENTILATOR, MODEL V8000 (January 9, 2009)
  • K072450 — ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000 (December 12, 2007)
  • K071212 — ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000 (July 30, 2007)
  • K051262 — ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000 (July 8, 2005)
  • K041412 — ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000 (June 18, 2004)
  • K034032 — PLV CONTINUUM VENTILATOR, MODEL P2000 (March 16, 2004)
  • K022750 — PLV CONTINUUM VENTILATOR, MODEL P1000 (November 20, 2003)
  • K023350 — ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS (November 6, 2002)

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