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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 the device name listed in this FDA 510(k) record. The listed applicant is Circadiance, LLC. It received FDA 510(k) clearance on 2016-04-05 under 510(k) 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. The listed applicant is Circadiance, LLC. The 510(k) number is K151683.

When did SleepWeaver Advance Pediatric Nasal CPAP Mask receive FDA 510(k) clearance?

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

Who is the listed applicant for SleepWeaver Advance Pediatric Nasal CPAP Mask?

The FDA 510(k) record lists Circadiance, LLC as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07234188POM vs HFNC for Hypoxemia Prevention in ChildrenCOMPLETEDNCT07515755Supplemental Oxygen and Oxygen Desaturations in ColonoscopiesNOT_YET_RECRUITINGNCT07600333CPAP vs High-Flow Nasal Cannula for Treating Sleep Apnea in ChildrenNOT_YET_RECRUITING

Other records listing Circadiance, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162905SleepWeaver 3D Nasal Mask

Related Devices (Code: BZD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.K252338MySleepDashSomnetics International, Inc. (Dba Transcend 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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