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FDA 510(k)

ESSENTIAL MRI PATIENT MONITOR

K-Number: K103700 · 2011-03-15

ApplicantInvivo Corporation
Decision Date2011-03-15
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ESSENTIAL MRI PATIENT MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Corporation. It received FDA 510(k) clearance on 2011-03-15 under 510(k) number K103700. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESSENTIAL MRI PATIENT MONITOR?

ESSENTIAL MRI PATIENT MONITOR is a medical device that received FDA 510(k) clearance on 2011-03-15. The listed applicant is Invivo Corporation. The 510(k) number is K103700.

When did ESSENTIAL MRI PATIENT MONITOR receive FDA 510(k) clearance?

ESSENTIAL MRI PATIENT MONITOR received FDA 510(k) clearance on 2011-03-15, under 510(k) number K103700.

Who is the listed applicant for ESSENTIAL MRI PATIENT MONITOR?

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 ESSENTIAL MRI PATIENT MONITOR?

The FDA product code for ESSENTIAL MRI PATIENT MONITOR is DQA.

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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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