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FDA 510(k)

3160 MRI PATIENT MONITORING SYSTEM

K-Number: K053462 · 2006-01-18

ApplicantInvivo Corporation
Decision Date2006-01-18
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

3160 MRI PATIENT MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Corporation. It received FDA 510(k) clearance on 2006-01-18 under 510(k) number K053462. 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 3160 MRI PATIENT MONITORING SYSTEM?

3160 MRI PATIENT MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2006-01-18. The listed applicant is Invivo Corporation. The 510(k) number is K053462.

When did 3160 MRI PATIENT MONITORING SYSTEM receive FDA 510(k) clearance?

3160 MRI PATIENT MONITORING SYSTEM received FDA 510(k) clearance on 2006-01-18, under 510(k) number K053462.

Who is the listed applicant for 3160 MRI PATIENT MONITORING SYSTEM?

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 3160 MRI PATIENT MONITORING SYSTEM?

The FDA product code for 3160 MRI PATIENT MONITORING SYSTEM 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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