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FDA 510(k)

DUOSTAR

K-Number: K974170 · 1998-09-30

ApplicantMti Corp./ Electrostar S.A.-Haiti
Decision Date1998-09-30
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DUOSTAR is the device name listed in this FDA 510(k) record. The listed applicant is Mti Corp./ Electrostar S.A.-Haiti. It received FDA 510(k) clearance on 1998-09-30 under 510(k) number K974170. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUOSTAR?

DUOSTAR is a medical device that received FDA 510(k) clearance on 1998-09-30. The listed applicant is Mti Corp./ Electrostar S.A.-Haiti. The 510(k) number is K974170.

When did DUOSTAR receive FDA 510(k) clearance?

DUOSTAR received FDA 510(k) clearance on 1998-09-30, under 510(k) number K974170.

Who is the listed applicant for DUOSTAR?

The FDA 510(k) record lists Mti Corp./ Electrostar S.A.-Haiti as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUOSTAR?

The FDA product code for DUOSTAR is GEI.

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Official Source

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