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)

FLLYNN(R) GENESIS AC

K-Number: K913039 · 1992-08-25

ApplicantO-Two Systems Intl., Inc.
Decision Date1992-08-25
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLLYNN(R) GENESIS AC is the device name listed in this FDA 510(k) record. The listed applicant is O-Two Systems Intl., Inc.. It received FDA 510(k) clearance on 1992-08-25 under 510(k) number K913039. 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 FLLYNN(R) GENESIS AC?

FLLYNN(R) GENESIS AC is a medical device that received FDA 510(k) clearance on 1992-08-25. The listed applicant is O-Two Systems Intl., Inc.. The 510(k) number is K913039.

When did FLLYNN(R) GENESIS AC receive FDA 510(k) clearance?

FLLYNN(R) GENESIS AC received FDA 510(k) clearance on 1992-08-25, under 510(k) number K913039.

Who is the listed applicant for FLLYNN(R) GENESIS AC?

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

What is the FDA product code for FLLYNN(R) GENESIS AC?

The FDA product code for FLLYNN(R) GENESIS AC 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 Systems Intl., 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.

K991195CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATVK983857AUTOVENT 1500K983705EMT RESUSCITATORK983785AUTOVENT 1000K983643GENESIS BLSK960995CPR BIO-BARRIER FACESHEILD

View all 14 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.

↑