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510(k) K034032

PLV CONTINUUM VENTILATOR, MODEL P2000 by Respironics California, Inc. — Product Code NOU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2004
Date Received
December 29, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device.

Other clearances by Respironics California, Inc.

  • K110083 — V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE (January 13, 2012)
  • 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)
  • K022750 — PLV CONTINUUM VENTILATOR, MODEL P1000 (November 20, 2003)
  • K023350 — ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS (November 6, 2002)

Other clearances for product code NOU

  • K233452 — Vivo 45 LS (January 13, 2025)
  • K193586 — Vivo 45 LS (January 27, 2021)
  • K160481 — Vivo 60 (November 9, 2016)
  • K123144 — VIVO 50 (June 18, 2013)
  • K022750 — PLV CONTINUUM VENTILATOR, MODEL P1000 (November 20, 2003)
  • K021981 — IVENT 201 PORTABLE VENTILATOR (August 13, 2003)