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FDA 510(k)

OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.)

K-Number: K941793 · 1995-06-21

ApplicantMountain Medical Equipment, Inc.
Decision Date1995-06-21
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.) is the device name listed in this FDA 510(k) record. The listed applicant is Mountain Medical Equipment, Inc.. It received FDA 510(k) clearance on 1995-06-21 under 510(k) number K941793. 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 CONCENTRATION STATUS INDICATOR (O.C.S.I.)?

OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.) is a medical device that received FDA 510(k) clearance on 1995-06-21. The listed applicant is Mountain Medical Equipment, Inc.. The 510(k) number is K941793.

When did OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.) receive FDA 510(k) clearance?

OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.) received FDA 510(k) clearance on 1995-06-21, under 510(k) number K941793.

Who is the listed applicant for OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.)?

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

What is the FDA product code for OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.)?

The FDA product code for OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.) is CCL.

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Other records listing Mountain Medical Equipment, 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.

K923650SCOTTYK924684MICROFLOWK914916ALPINE VK902890ASPEN 3 OXYGEN CONCENTRATORK893531CUFF SPECULUMK884084PORTABLE OXYGEN GENERATOR

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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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