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FDA 510(k)

MINIOX 3000 OXYGEN MONITOR

K-Number: K961644 · 1996-07-25

ApplicantMinesafety Appliances Co.
Decision Date1996-07-25
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MINIOX 3000 OXYGEN MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Minesafety Appliances Co.. It received FDA 510(k) clearance on 1996-07-25 under 510(k) number K961644. 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 MINIOX 3000 OXYGEN MONITOR?

MINIOX 3000 OXYGEN MONITOR is a medical device that received FDA 510(k) clearance on 1996-07-25. The listed applicant is Minesafety Appliances Co.. The 510(k) number is K961644.

When did MINIOX 3000 OXYGEN MONITOR receive FDA 510(k) clearance?

MINIOX 3000 OXYGEN MONITOR received FDA 510(k) clearance on 1996-07-25, under 510(k) number K961644.

Who is the listed applicant for MINIOX 3000 OXYGEN MONITOR?

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

What is the FDA product code for MINIOX 3000 OXYGEN MONITOR?

The FDA product code for MINIOX 3000 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 Minesafety Appliances 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.

K935370MINIOX IA OXYGEN ANALYZERK935364MINIOX 1000 OXYGEN CONCENTRATION INDICATORK903200MINICAP III CO2 DETECTORK883090MINICAP TM 100 CAPNOMETER

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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