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FDA 510(k)

MODIFICATION TO: HORIZON 9000WS

K-Number: K032997 · 2003-10-15

ApplicantMennen Medical , Ltd.
Decision Date2003-10-15
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: HORIZON 9000WS is the device name listed in this FDA 510(k) record. The listed applicant is Mennen Medical , Ltd.. It received FDA 510(k) clearance on 2003-10-15 under 510(k) number K032997. 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 MODIFICATION TO: HORIZON 9000WS?

MODIFICATION TO: HORIZON 9000WS is a medical device that received FDA 510(k) clearance on 2003-10-15. The listed applicant is Mennen Medical , Ltd.. The 510(k) number is K032997.

When did MODIFICATION TO: HORIZON 9000WS receive FDA 510(k) clearance?

MODIFICATION TO: HORIZON 9000WS received FDA 510(k) clearance on 2003-10-15, under 510(k) number K032997.

Who is the listed applicant for MODIFICATION TO: HORIZON 9000WS?

The FDA 510(k) record lists Mennen Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO: HORIZON 9000WS?

The FDA product code for MODIFICATION TO: HORIZON 9000WS is DXG.

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Other records listing Mennen Medical , Ltd. 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.

K131789CEREBRALOGIK- AEEGK123792HORIZON XVU (FFR)K093766VITALOGIK 6000/6500K091165HORIZON XVUK083063BIS INTERFACE FOR VITALOGIK PATIENT MONITORSK081484HORIZON XVU

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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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