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FDA 510(k)

BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S

K-Number: K100528 · 2010-04-23

ApplicantBreathe Technologies, Inc.
Decision Date2010-04-23
Product CodeONZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S 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 2010-04-23 under 510(k) number K100528. 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 BT-V2S?

BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S is a medical device that received FDA 510(k) clearance on 2010-04-23. The listed applicant is Breathe Technologies, Inc.. The 510(k) number is K100528.

When did BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S receive FDA 510(k) clearance?

BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S received FDA 510(k) clearance on 2010-04-23, under 510(k) number K100528.

Who is the listed applicant for BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S?

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 BT-V2S?

The FDA product code for BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S 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)K082982BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES

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.K082982BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIESBreathe 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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