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FDA 510(k)

SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK

K-Number: K130481 · 2013-05-24

ApplicantCircadiance, LLC
Decision Date2013-05-24
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP 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 2013-05-24 under 510(k) number K130481. 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 ANEW FULL FACE SOFT CLOTH PAP MASK?

SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK is a medical device that received FDA 510(k) clearance on 2013-05-24. The listed applicant is Circadiance, LLC. The 510(k) number is K130481.

When did SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK receive FDA 510(k) clearance?

SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK received FDA 510(k) clearance on 2013-05-24, under 510(k) number K130481.

Who is the listed applicant for SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP 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 ANEW FULL FACE SOFT CLOTH PAP MASK?

The FDA product code for SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_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 MaskK151683SleepWeaver Advance Pediatric Nasal CPAP MaskK120757SLEEPWEAVER ELAN NASAL CPAP MASKK092362SLEEPWEAVER 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.

K261262Altis Full Face MaskRespironics, Inc.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.

Official Source

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

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