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510(k) K121321

HARD SHELL VENTED NASAL MASK by Sleepnet Corporation — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2012
Date Received
May 2, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

Other clearances by Sleepnet Corporation

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  • 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)
  • 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)

Other clearances for product code BZD

  • K251847 — Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask (January 15, 2026)
  • K253939 — DeltaWave Nasal Pillow System (January 7, 2026)
  • K251770 — SleepRes PAP System (December 15, 2025)
  • K251657 — Personalized Therapy Comfort Settings (PTCS) (December 5, 2025)
  • K243583 — F&P Nova Nasal Mask (June 18, 2025)
  • K250624 — myAir (May 28, 2025)
  • K243023 — WiZARD 520 Full Face Mask (May 23, 2025)
  • K242547 — AirFit F20 Mask System; AirFit F20 NM Mask System (May 19, 2025)
  • K242935 — Respiration Data Management Software (PAP Link PC) (January 15, 2025)
  • K243225 — Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-0 (December 31, 2024)