Home / 510(k) Clearances / K071212

510(k) K071212

ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000 by Respironics California, Inc. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2007
Date Received
May 1, 2007
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.

  • 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)
  • 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)

Other clearances for product code CBK

  • K251888 — VPAP Pediatric Face Mask (March 12, 2026)
  • K232365 — Vivo 45 LS (December 19, 2025)
  • K252173 — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits (September 10, 2025)
  • K243767 — SV600, SV800 Ventilator (August 28, 2025)
  • K251133 — AVEA disposable expiratory filter/water trap (11790) (May 8, 2025)
  • K243394 — AF531 Oro-Nasal SE Face Mask (December 30, 2024)
  • K233486 — 731 Series Ventilator (December 13, 2024)
  • K223120 — Ventoux VC2; Ventoux VC3 (December 2, 2024)
  • K241135 — RESPOND(R) Ventilator (November 13, 2024)
  • K241943 — Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 (August 28, 2024)