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FDA 510(k)

BREATHE CPAP SYSTEM

K-Number: K130037 · 2013-05-17

ApplicantBreathe Technologies, Inc.
Decision Date2013-05-17
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BREATHE CPAP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Breathe Technologies, Inc.. It received FDA 510(k) clearance on 2013-05-17 under 510(k) number K130037. 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 BREATHE CPAP SYSTEM?

BREATHE CPAP SYSTEM is a medical device that received FDA 510(k) clearance on 2013-05-17. The listed applicant is Breathe Technologies, Inc.. The 510(k) number is K130037.

When did BREATHE CPAP SYSTEM receive FDA 510(k) clearance?

BREATHE CPAP SYSTEM received FDA 510(k) clearance on 2013-05-17, under 510(k) number K130037.

Who is the listed applicant for BREATHE CPAP SYSTEM?

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

What is the FDA product code for BREATHE CPAP SYSTEM?

The FDA product code for BREATHE CPAP SYSTEM 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 Breathe Technologies, Inc. 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.

K103345BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)K102525BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)K100528BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2SK082982BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES

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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