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FDA 510(k)

SleepWeaver 3D Nasal Mask

K-Number: K162905 · 2017-03-15

ApplicantCircadiance, LLC
Decision Date2017-03-15
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SleepWeaver 3D Nasal 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 2017-03-15 under 510(k) number K162905. 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 3D Nasal Mask?

SleepWeaver 3D Nasal Mask is a medical device that received FDA 510(k) clearance on 2017-03-15. The listed applicant is Circadiance, LLC. The 510(k) number is K162905.

When did SleepWeaver 3D Nasal Mask receive FDA 510(k) clearance?

SleepWeaver 3D Nasal Mask received FDA 510(k) clearance on 2017-03-15, under 510(k) number K162905.

Who is the listed applicant for SleepWeaver 3D Nasal 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 3D Nasal Mask?

The FDA product code for SleepWeaver 3D Nasal Mask is BZD.

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.

K151683SleepWeaver Advance Pediatric Nasal CPAP 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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