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FDA 510(k)

VITALOGIK 6000/6500

K-Number: K093766 · 2010-05-07

ApplicantMennen Medical , Ltd.
Decision Date2010-05-07
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VITALOGIK 6000/6500 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 2010-05-07 under 510(k) number K093766. 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 VITALOGIK 6000/6500?

VITALOGIK 6000/6500 is a medical device that received FDA 510(k) clearance on 2010-05-07. The listed applicant is Mennen Medical , Ltd.. The 510(k) number is K093766.

When did VITALOGIK 6000/6500 receive FDA 510(k) clearance?

VITALOGIK 6000/6500 received FDA 510(k) clearance on 2010-05-07, under 510(k) number K093766.

Who is the listed applicant for VITALOGIK 6000/6500?

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 VITALOGIK 6000/6500?

The FDA product code for VITALOGIK 6000/6500 is DSI.

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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)K091165HORIZON XVUK083063BIS INTERFACE FOR VITALOGIK PATIENT MONITORSK081484HORIZON XVUK073140VITALOGIK MODEL 4000/4500

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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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

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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