Home / 510(k) Clearances / K241943

510(k) K241943

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2024
Date Received
July 2, 2024
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)
  • 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)
  • K190533 — Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal (July 26, 2019)
  • 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)

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