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FDA 510(k)

HORIZON 9000

K-Number: K875167 · 1988-05-31

ApplicantMennen Medical, Inc.
Decision Date1988-05-31
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HORIZON 9000 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 1988-05-31 under 510(k) number K875167. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HORIZON 9000?

HORIZON 9000 is a medical device that received FDA 510(k) clearance on 1988-05-31. The listed applicant is Mennen Medical, Inc.. The 510(k) number is K875167.

When did HORIZON 9000 receive FDA 510(k) clearance?

HORIZON 9000 received FDA 510(k) clearance on 1988-05-31, under 510(k) number K875167.

Who is the listed applicant for HORIZON 9000?

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 9000?

The FDA product code for HORIZON 9000 is DXG.

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Other records listing Mennen Medical, 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.

K030722ENVOY PATIENT MONITORK983864ETCO2 VITAL SIGNS MODULEK991775MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WSK982697MODIFICATION TO ENSEMBLE CENTRAL STATION MONITORK974510ENVOY PATIENT MONITORK970358ENSEMBLE CENTRAL STATION MONITOR

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Related Devices (Code: DXG)

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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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