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FDA 510(k)

MONO 2 OXYGEN MONITOR

K-Number: K812587 · 1981-10-06

ApplicantKantron Cardiovascular, Inc.
Decision Date1981-10-06
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MONO 2 OXYGEN MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Kantron Cardiovascular, Inc.. It received FDA 510(k) clearance on 1981-10-06 under 510(k) number K812587. The device is classified under product code CCL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONO 2 OXYGEN MONITOR?

MONO 2 OXYGEN MONITOR is a medical device that received FDA 510(k) clearance on 1981-10-06. The listed applicant is Kantron Cardiovascular, Inc.. The 510(k) number is K812587.

When did MONO 2 OXYGEN MONITOR receive FDA 510(k) clearance?

MONO 2 OXYGEN MONITOR received FDA 510(k) clearance on 1981-10-06, under 510(k) number K812587.

Who is the listed applicant for MONO 2 OXYGEN MONITOR?

The FDA 510(k) record lists Kantron Cardiovascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONO 2 OXYGEN MONITOR?

The FDA product code for MONO 2 OXYGEN MONITOR is CCL.

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 Kantron Cardiovascular, 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.

K812586KANTRON 504 HEARTSTATION

Related Devices (Code: CCL)

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.

K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter LabsK251245OxyMinder Pro (10310)Bio-Med Device, Inc.K250002Smart Check O2 (MA0236)Life Spark Medical, LLCK221734Maxtec MaxO2 ME+pMaxtec, LLCK213933Percent Oxygen SensorsCareox, LLCK213948OxyMinderBio-Med Devices, 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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