Home / 510(k) Clearances / K190533

510(k) K190533

Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented by Sleepnet Corporation — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2019
Date Received
March 4, 2019
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 Sleepnet Corporation

  • K251847 — Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask (January 15, 2026)
  • K241830 — Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face V (October 18, 2024)
  • K241943 — Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 (August 28, 2024)
  • K241661 — Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Ven (July 10, 2024)
  • K241520 — Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal (June 27, 2024)
  • K241469 — iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask (June 15, 2024)
  • K211274 — iQ 2 Nasal Mask, Phantom 2 Nasal Mask (January 10, 2022)
  • K203601 — Innova Nasal Non-Vented Mask (April 30, 2021)
  • K190254 — Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Ven (July 5, 2019)
  • K121321 — HARD SHELL VENTED NASAL MASK (November 30, 2012)

Other clearances for product code CBK

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  • 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)