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510(k) K162905

SleepWeaver 3D Nasal Mask by Circadiance, LLC — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2017
Date Received
October 17, 2016
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

  • K151683 — SleepWeaver Advance Pediatric Nasal CPAP Mask (April 5, 2016)
  • 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)

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