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FDA 510(k)

HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP.

K-Number: K894918 · 1989-10-31

ApplicantMennen Medical, Inc.
Decision Date1989-10-31
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP. is the device name listed in this FDA 510(k) record. The listed applicant is Mennen Medical, Inc.. It received FDA 510(k) clearance on 1989-10-31 under 510(k) number K894918. 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 HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP.?

HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP. is a medical device that received FDA 510(k) clearance on 1989-10-31. The listed applicant is Mennen Medical, Inc.. The 510(k) number is K894918.

When did HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP. receive FDA 510(k) clearance?

HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP. received FDA 510(k) clearance on 1989-10-31, under 510(k) number K894918.

Who is the listed applicant for HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP.?

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

What is the FDA product code for HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP.?

The FDA product code for HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP. is CCL.

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Other records listing Mennen Medical, Inc. as applicant

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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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