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FDA 510(k)

MINI OX II

K-Number: K833995 · 1983-12-12

ApplicantCatalyst Research Corp.
Decision Date1983-12-12
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MINI OX II is the device name listed in this FDA 510(k) record. The listed applicant is Catalyst Research Corp.. It received FDA 510(k) clearance on 1983-12-12 under 510(k) number K833995. 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 MINI OX II?

MINI OX II is a medical device that received FDA 510(k) clearance on 1983-12-12. The listed applicant is Catalyst Research Corp.. The 510(k) number is K833995.

When did MINI OX II receive FDA 510(k) clearance?

MINI OX II received FDA 510(k) clearance on 1983-12-12, under 510(k) number K833995.

Who is the listed applicant for MINI OX II?

The FDA 510(k) record lists Catalyst Research Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MINI OX II?

The FDA product code for MINI OX II is CCL.

Other records listing Catalyst Research Corp. 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.

K905310MINIOX V PULSE OXIMETERK874132MINIOX IV PORTABLE PULSE OXIMETERK862798MINIOX 100 PULSE OXIMETERK833326MINI OX III OXYGEN MONITORK790785MODEL M25RL, (CRC) OXYGEN ANALYZERK790784MODEL M25R, OXYGEN ANALYZER

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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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