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FDA 510(k)

BIS INTERFACE FOR VITALOGIK PATIENT MONITORS

K-Number: K083063 · 2008-12-16

ApplicantMennen Medical , Ltd.
Decision Date2008-12-16
Product CodeOLW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIS INTERFACE FOR VITALOGIK PATIENT MONITORS 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 2008-12-16 under 510(k) number K083063. The device is classified under product code OLW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIS INTERFACE FOR VITALOGIK PATIENT MONITORS?

BIS INTERFACE FOR VITALOGIK PATIENT MONITORS is a medical device that received FDA 510(k) clearance on 2008-12-16. The listed applicant is Mennen Medical , Ltd.. The 510(k) number is K083063.

When did BIS INTERFACE FOR VITALOGIK PATIENT MONITORS receive FDA 510(k) clearance?

BIS INTERFACE FOR VITALOGIK PATIENT MONITORS received FDA 510(k) clearance on 2008-12-16, under 510(k) number K083063.

Who is the listed applicant for BIS INTERFACE FOR VITALOGIK PATIENT MONITORS?

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 BIS INTERFACE FOR VITALOGIK PATIENT MONITORS?

The FDA product code for BIS INTERFACE FOR VITALOGIK PATIENT MONITORS is OLW.

Related Clinical Trials

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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 XVUK081484HORIZON XVUK073140VITALOGIK MODEL 4000/4500

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Related Devices (Code: OLW)

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.

K260907BIS™ Advance pEEG ModuleCovidien LPK260880SedLine Sedation MonitorMasimo CorporationK230693BIS™ Advance Monitoring SystemCovidien, LLCK213273Brain Anesthesia Response Monitor (Bar Monitor)Cortical Dynamics , Ltd.K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo CorporationK202621NeuroSENSE Monitoring System, Model NS-901Neurowave Systems, Inc.

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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