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FDA 510(k)

OXYGEN MONITOR OHIO 5100

K-Number: K830446 · 1983-03-24

ApplicantAirco/Ohio Medical Products
Decision Date1983-03-24
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYGEN MONITOR OHIO 5100 is the device name listed in this FDA 510(k) record. The listed applicant is Airco/Ohio Medical Products. It received FDA 510(k) clearance on 1983-03-24 under 510(k) number K830446. 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 OXYGEN MONITOR OHIO 5100?

OXYGEN MONITOR OHIO 5100 is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is Airco/Ohio Medical Products. The 510(k) number is K830446.

When did OXYGEN MONITOR OHIO 5100 receive FDA 510(k) clearance?

OXYGEN MONITOR OHIO 5100 received FDA 510(k) clearance on 1983-03-24, under 510(k) number K830446.

Who is the listed applicant for OXYGEN MONITOR OHIO 5100?

The FDA 510(k) record lists Airco/Ohio Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OXYGEN MONITOR OHIO 5100?

The FDA product code for OXYGEN MONITOR OHIO 5100 is CCL.

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Other records listing Airco/Ohio Medical Products 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.

K833459COAXIAL VOL. VENTILATOR CIRCUITK833452OHIO GMS ABSORBERK832418OHIO TEMPERATURE SIMULATORK832565OHIO 5400 VOLUME MONITORK832185OHIO MODEL 922 SPIROMETERK822456OHIO V5A ANESTHESIA VENTILATOR

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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