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FDA 510(k)

HORIZON 1100 CARDIAC MONITOR

K-Number: K864843 · 1987-03-16

ApplicantMennen Medical, Inc.
Decision Date1987-03-16
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HORIZON 1100 CARDIAC 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 1987-03-16 under 510(k) number K864843. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HORIZON 1100 CARDIAC MONITOR?

HORIZON 1100 CARDIAC MONITOR is a medical device that received FDA 510(k) clearance on 1987-03-16. The listed applicant is Mennen Medical, Inc.. The 510(k) number is K864843.

When did HORIZON 1100 CARDIAC MONITOR receive FDA 510(k) clearance?

HORIZON 1100 CARDIAC MONITOR received FDA 510(k) clearance on 1987-03-16, under 510(k) number K864843.

Who is the listed applicant for HORIZON 1100 CARDIAC 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 1100 CARDIAC MONITOR?

The FDA product code for HORIZON 1100 CARDIAC MONITOR is DPS.

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Other records listing Mennen Medical, Inc. as applicant

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Related Devices (Code: DPS)

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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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