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FDA 510(k)

HORIZON PACEMAKER DETECTION SOFTWARE

K-Number: K913339 · 1992-01-08

ApplicantMennen Medical, Inc.
Decision Date1992-01-08
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HORIZON PACEMAKER DETECTION SOFTWARE 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 1992-01-08 under 510(k) number K913339. 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 PACEMAKER DETECTION SOFTWARE?

HORIZON PACEMAKER DETECTION SOFTWARE is a medical device that received FDA 510(k) clearance on 1992-01-08. The listed applicant is Mennen Medical, Inc.. The 510(k) number is K913339.

When did HORIZON PACEMAKER DETECTION SOFTWARE receive FDA 510(k) clearance?

HORIZON PACEMAKER DETECTION SOFTWARE received FDA 510(k) clearance on 1992-01-08, under 510(k) number K913339.

Who is the listed applicant for HORIZON PACEMAKER DETECTION SOFTWARE?

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 PACEMAKER DETECTION SOFTWARE?

The FDA product code for HORIZON PACEMAKER DETECTION SOFTWARE is DSI.

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Other records listing Mennen Medical, Inc. as applicant

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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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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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