Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CAREVENT HANDHELD CPAP SYSTEM

K-Number: K093862 · 2010-05-06

ApplicantO-Two Medical Technologies, Inc.
Decision Date2010-05-06
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CAREVENT HANDHELD CPAP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is O-Two Medical Technologies, Inc.. It received FDA 510(k) clearance on 2010-05-06 under 510(k) number K093862. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAREVENT HANDHELD CPAP SYSTEM?

CAREVENT HANDHELD CPAP SYSTEM is a medical device that received FDA 510(k) clearance on 2010-05-06. The listed applicant is O-Two Medical Technologies, Inc.. The 510(k) number is K093862.

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

CAREVENT HANDHELD CPAP SYSTEM received FDA 510(k) clearance on 2010-05-06, under 510(k) number K093862.

Who is the listed applicant for CAREVENT HANDHELD CPAP SYSTEM?

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

What is the FDA product code for CAREVENT HANDHELD CPAP SYSTEM?

The FDA product code for CAREVENT HANDHELD CPAP SYSTEM is BTL.

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 O-Two Medical 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.

K173205Equinox AdvantageK113687EQUINOX RELIEVEK112546O_TWO CPAP SYSTEMK081330CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)K051469CAREVENT ATV+ AND CAREVENT MRIK051889CAREVENT CA AND DRA

View all 7 devices →

Related Devices (Code: BTL)

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.

K242769VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)Draegerwerk AG & CO KgaaK221634Oxymag - Transport and Emergency VentilatorMagnamed Tecnologia Medica S/AK202219VORTRAN GO2VENT with PEEP ValveVortran Medical Technology 1, Inc.K193191MEDUMAT Easy CPR, MEDUMAT Easy CPR with bagWeinmann Emergency Medical Technology GmbH + Co. KGK182956Puffin Lite Infant Resuscitation SystemInternational BiomedicalK173373SafeT T-Piece ResuscitatorVentlab, LLC

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.

↑