Home / 510(k) Clearances / K081670

510(k) K081670

THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK by Cardinal Health 207, Inc. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2008
Date Received
June 13, 2008
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 Cardinal Health 207, Inc.

  • K093094 — VELA VENTILATOR (May 11, 2010)
  • K092484 — HELIOX LOW FLOW SENTRY BLENDER (April 2, 2010)
  • K093124 — PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, M (March 10, 2010)
  • K081837 — AVEA VENTILATOR (August 13, 2008)

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)