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)

RESUSCITATOR MODELS 10400/10500/10600/10700/10800

K-Number: K862192 · 1986-07-07

ApplicantU.O. Equipment Co.
Decision Date1986-07-07
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESUSCITATOR MODELS 10400/10500/10600/10700/10800 is the device name listed in this FDA 510(k) record. The listed applicant is U.O. Equipment Co.. It received FDA 510(k) clearance on 1986-07-07 under 510(k) number K862192. 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 RESUSCITATOR MODELS 10400/10500/10600/10700/10800?

RESUSCITATOR MODELS 10400/10500/10600/10700/10800 is a medical device that received FDA 510(k) clearance on 1986-07-07. The listed applicant is U.O. Equipment Co.. The 510(k) number is K862192.

When did RESUSCITATOR MODELS 10400/10500/10600/10700/10800 receive FDA 510(k) clearance?

RESUSCITATOR MODELS 10400/10500/10600/10700/10800 received FDA 510(k) clearance on 1986-07-07, under 510(k) number K862192.

Who is the listed applicant for RESUSCITATOR MODELS 10400/10500/10600/10700/10800?

The FDA 510(k) record lists U.O. Equipment Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESUSCITATOR MODELS 10400/10500/10600/10700/10800?

The FDA product code for RESUSCITATOR MODELS 10400/10500/10600/10700/10800 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 U.O. Equipment Co. 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.

K862194INHALATOR MODELS 8100, 10100 AND 10200K862193# 10099/10225/10235/10275/10525/10625/10715/10125

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.

↑