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FDA 510(k)

Breathe Technologies Life2000™ Ventilation System

K-Number: K170037 · 2017-08-11

ApplicantBreathe Technologies
Decision Date2017-08-11
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Breathe Technologies Life2000™ Ventilation System is a medical device manufactured by Breathe Technologies. It received FDA 510(k) clearance on 2017-08-11 under approval number K170037. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Breathe Technologies Life2000™ Ventilation System?

Breathe Technologies Life2000™ Ventilation System is a medical device that received FDA 510(k) clearance on 2017-08-11. It is manufactured by Breathe Technologies. The 510(k) number is K170037.

When was Breathe Technologies Life2000™ Ventilation System approved by the FDA?

Breathe Technologies Life2000™ Ventilation System received FDA 510(k) clearance on 2017-08-11, under approval number K170037.

What company makes Breathe Technologies Life2000™ Ventilation System?

Breathe Technologies Life2000™ Ventilation System is manufactured by Breathe Technologies.

What is the FDA product code for Breathe Technologies Life2000™ Ventilation System?

The FDA product code for Breathe Technologies Life2000™ Ventilation System is CBK.

Related Clinical Trials

NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT02389166 Optiflow in Sequential Non-Invasive Ventilation COMPLETED NCT06861309 Placental Imaging Techniques RECRUITING NCT05687292 Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery in Children RECRUITING

Related PubMed Literature

PMID: 41608759 Collaborative and Cooperative Hospital "In-House" Medical Device Development and Implementation in the AI Age: The European Responsible AI Development (EURAID) Framework Compatible With European Values. Journal of medical Internet research (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025)

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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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