FDA 510(k)

INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM

K-Number: K061640 · 2006-07-27

ApplicantIntegra LifeSciences Corporation

Decision Date2006-07-27

Product CodeGWM

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2006-07-27 under 510(k) number K061640. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM?

INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2006-07-27. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K061640.

When did INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM receive FDA 510(k) clearance?

INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM received FDA 510(k) clearance on 2006-07-27, under 510(k) number K061640.

Who is the listed applicant for INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM?

The FDA 510(k) record lists Integra LifeSciences Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM?

The FDA product code for INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM is GWM.

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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.