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FDA 510(k)

MRI PATIENT MONITORING SYSTEM (MODEL 865214)

K-Number: K124061 · 2013-02-22

ApplicantInvivo Corporation
Decision Date2013-02-22
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MRI PATIENT MONITORING SYSTEM (MODEL 865214) is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Corporation. It received FDA 510(k) clearance on 2013-02-22 under 510(k) number K124061. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRI PATIENT MONITORING SYSTEM (MODEL 865214)?

MRI PATIENT MONITORING SYSTEM (MODEL 865214) is a medical device that received FDA 510(k) clearance on 2013-02-22. The listed applicant is Invivo Corporation. The 510(k) number is K124061.

When did MRI PATIENT MONITORING SYSTEM (MODEL 865214) receive FDA 510(k) clearance?

MRI PATIENT MONITORING SYSTEM (MODEL 865214) received FDA 510(k) clearance on 2013-02-22, under 510(k) number K124061.

Who is the listed applicant for MRI PATIENT MONITORING SYSTEM (MODEL 865214)?

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

What is the FDA product code for MRI PATIENT MONITORING SYSTEM (MODEL 865214)?

The FDA product code for MRI PATIENT MONITORING SYSTEM (MODEL 865214) is MWI.

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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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