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FDA 510(k)

BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES

K-Number: K082982 · 2009-07-20

ApplicantBreathe Technologies, Inc.
Decision Date2009-07-20
Product CodeONZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES 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 2009-07-20 under 510(k) number K082982. The device is classified under product code ONZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES?

BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2009-07-20. The listed applicant is Breathe Technologies, Inc.. The 510(k) number is K082982.

When did BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES receive FDA 510(k) clearance?

BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES received FDA 510(k) clearance on 2009-07-20, under 510(k) number K082982.

Who is the listed applicant for BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES?

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 TECHNOLOGIES VENTILATOR AND ACCESSORIES?

The FDA product code for BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES is ONZ.

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.

K130037BREATHE CPAP SYSTEMK103345BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)K102525BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)K100528BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S

Related Devices (Code: ONZ)

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.

K152664TAV SystemNew Aera, Inc.K103345BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)Breathe Technologies, Inc.K102525BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)Breathe Technologies, Inc.K100528BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2SBreathe Technologies, Inc.

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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