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FDA 510(k)

HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS)

K-Number: K885204 · 1989-04-19

ApplicantMennen Medical, Inc.
Decision Date1989-04-19
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS) 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 1989-04-19 under 510(k) number K885204. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS)?

HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS) is a medical device that received FDA 510(k) clearance on 1989-04-19. The listed applicant is Mennen Medical, Inc.. The 510(k) number is K885204.

When did HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS) receive FDA 510(k) clearance?

HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS) received FDA 510(k) clearance on 1989-04-19, under 510(k) number K885204.

Who is the listed applicant for HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS)?

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 ARRHYTHMIA MONITOR OPTION - (ALARMS)?

The FDA product code for HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS) is DSI.

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Related Devices (Code: DSI)

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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