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FDA 510(k)

HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR

K-Number: K850879 · 1985-04-25

ApplicantMennen Medical, Inc.
Decision Date1985-04-25
Product CodeDSK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR 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 1985-04-25 under 510(k) number K850879. The device is classified under product code DSK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR?

HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR is a medical device that received FDA 510(k) clearance on 1985-04-25. The listed applicant is Mennen Medical, Inc.. The 510(k) number is K850879.

When did HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR receive FDA 510(k) clearance?

HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR received FDA 510(k) clearance on 1985-04-25, under 510(k) number K850879.

Who is the listed applicant for HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR?

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 PHYSIOLOGICAL PATIENT MONITOR?

The FDA product code for HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR is DSK.

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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.

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Related Devices (Code: DSK)

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.

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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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