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FDA 510(k)

ENVOY PATIENT MONITOR

K-Number: K024245 · 2004-05-10

ApplicantMennen Medical , Ltd.
Decision Date2004-05-10
Product CodeOMC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ENVOY PATIENT MONITOR 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 2004-05-10 under 510(k) number K024245. The device is classified under product code OMC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENVOY PATIENT MONITOR?

ENVOY PATIENT MONITOR is a medical device that received FDA 510(k) clearance on 2004-05-10. The listed applicant is Mennen Medical , Ltd.. The 510(k) number is K024245.

When did ENVOY PATIENT MONITOR receive FDA 510(k) clearance?

ENVOY PATIENT MONITOR received FDA 510(k) clearance on 2004-05-10, under 510(k) number K024245.

Who is the listed applicant for ENVOY PATIENT MONITOR?

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 ENVOY PATIENT MONITOR?

The FDA product code for ENVOY PATIENT MONITOR is OMC.

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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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Related Devices (Code: OMC)

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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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