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510(k) K120757

SLEEPWEAVER ELAN NASAL CPAP MASK by Circadiance, LLC — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2012
Date Received
March 13, 2012
Clearance Type
Special
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)
  • K151683 — SleepWeaver Advance Pediatric Nasal CPAP Mask (April 5, 2016)
  • K130481 — SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK (May 24, 2013)
  • K092362 — SLEEPWEAVER NASAL CPAP MASK (November 2, 2009)

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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)
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  • K242935 — Respiration Data Management Software (PAP Link PC) (January 15, 2025)
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