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510(k) K151683

SleepWeaver Advance Pediatric Nasal CPAP Mask by Circadiance, LLC — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2016
Date Received
June 22, 2015
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 Circadiance, LLC

  • K162905 — SleepWeaver 3D Nasal Mask (March 15, 2017)
  • K130481 — SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK (May 24, 2013)
  • K120757 — SLEEPWEAVER ELAN NASAL CPAP MASK (April 24, 2012)
  • K092362 — SLEEPWEAVER NASAL CPAP MASK (November 2, 2009)

Other clearances for product code BZD

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  • 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)