FDA 510(k)

MENTOR MDS

K-Number: K885155 · 1989-03-14

ApplicantImex

Decision Date1989-03-14

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MENTOR MDS is the device name listed in this FDA 510(k) record. The listed applicant is Imex. It received FDA 510(k) clearance on 1989-03-14 under 510(k) number K885155. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR MDS?

MENTOR MDS is a medical device that received FDA 510(k) clearance on 1989-03-14. The listed applicant is Imex. The 510(k) number is K885155.

When did MENTOR MDS receive FDA 510(k) clearance?

MENTOR MDS received FDA 510(k) clearance on 1989-03-14, under 510(k) number K885155.

Who is the listed applicant for MENTOR MDS?

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

What is the FDA product code for MENTOR MDS?

The FDA product code for MENTOR MDS is IYN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.