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FDA 510(k)

SleepWeaver Advance Pediatric Nasal CPAP Mask

K-Number: K151683 · 2016-04-05

ApplicantCircadiance, LLC
Decision Date2016-04-05
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SleepWeaver Advance Pediatric Nasal CPAP Mask is a medical device manufactured by Circadiance, LLC. It received FDA 510(k) clearance on 2016-04-05 under approval number K151683. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SleepWeaver Advance Pediatric Nasal CPAP Mask?

SleepWeaver Advance Pediatric Nasal CPAP Mask is a medical device that received FDA 510(k) clearance on 2016-04-05. It is manufactured by Circadiance, LLC. The 510(k) number is K151683.

When was SleepWeaver Advance Pediatric Nasal CPAP Mask approved by the FDA?

SleepWeaver Advance Pediatric Nasal CPAP Mask received FDA 510(k) clearance on 2016-04-05, under approval number K151683.

What company makes SleepWeaver Advance Pediatric Nasal CPAP Mask?

SleepWeaver Advance Pediatric Nasal CPAP Mask is manufactured by Circadiance, LLC.

What is the FDA product code for SleepWeaver Advance Pediatric Nasal CPAP Mask?

The FDA product code for SleepWeaver Advance Pediatric Nasal CPAP Mask is BZD.

Related Clinical Trials

NCT07611903 HFNC Versus Microstream Advance Nasal Cannula for Oxygenation During ERCP NOT_YET_RECRUITING NCT07234188 POM vs HFNC for Hypoxemia Prevention in Children COMPLETED NCT07564050 Physiological Effects of Different Preoxygenation Strategies RECRUITING NCT03216837 Stimulation for Perinatal Stroke Optimizing Recovery Trajectories COMPLETED NCT07563075 Effect of High-Flow Nasal Cannula Oxygen Therapy on Hypoxemia in Pediatric Sedated Bronchoscopy NOT_YET_RECRUITING NCT06364280 Pediatric Prehospital Airway Resuscitation Trial SUSPENDED

Other Devices by Circadiance, LLC

K162905SleepWeaver 3D Nasal Mask

Related Devices (Code: BZD)

K160836Menai SystemResmed, Ltd. K161978AirFit N20Resmed, Ltd. K160127iCodeConnect3B Medical, Inc. K153505F&P Eson 2 Nasal MaskFisher & Paykel Healthcare Limited K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd. K153387Luna CPAP and Auto CPAP System3B Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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