Home / 510(k) Clearances / K070899

510(k) K070899

PURITAN BENNETT LEGENDAIR XL2 by Nellcor Puritan Bennett — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2007
Date Received
April 2, 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 Nellcor Puritan Bennett

  • K070408 — DURAMAX REUSABLE OXIMETRY SENSOR (May 25, 2007)
  • K060576 — NELLCOR OXIMAX N-600X PULSE OXIMETER (August 14, 2006)
  • K051271 — OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR (January 10, 2006)
  • K052186 — NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P (November 10, 2005)
  • K051352 — OXIMAX NPB-40 HANDHELD PULSE OXIMETER (August 11, 2005)
  • K050072 — GOODKNIGHT 425ST (June 13, 2005)
  • K033973 — OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR (December 13, 2004)
  • K030787 — SHILEY FLEXTRA TRACHEOSTOMY TUBE (November 14, 2003)
  • K030930 — OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N (May 23, 2003)
  • K023494 — NELLCOR INDGO MANUAL RESUSCITATOR (February 7, 2003)

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)