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FDA 510(k)

MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160

K-Number: K050399 · 2005-08-26

ApplicantInvivo Research, Inc.
Decision Date2005-08-26
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160 is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Research, Inc.. It received FDA 510(k) clearance on 2005-08-26 under 510(k) number K050399. 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 COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160?

MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160 is a medical device that received FDA 510(k) clearance on 2005-08-26. The listed applicant is Invivo Research, Inc.. The 510(k) number is K050399.

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

MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160 received FDA 510(k) clearance on 2005-08-26, under 510(k) number K050399.

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

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

What is the FDA product code for MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160?

The FDA product code for MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160 is MWI.

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Other records listing Invivo Research, Inc. as applicant

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Related Devices (Code: MWI)

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.

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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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