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FDA 510(k)

SPECIMEX DC

K-Number: K900740 · 1990-05-11

ApplicantSoredex Medical Systems
Decision Date1990-05-11
Product CodeGXZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPECIMEX DC is the device name listed in this FDA 510(k) record. The listed applicant is Soredex Medical Systems. It received FDA 510(k) clearance on 1990-05-11 under 510(k) number K900740. The device is classified under product code GXZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECIMEX DC?

SPECIMEX DC is a medical device that received FDA 510(k) clearance on 1990-05-11. The listed applicant is Soredex Medical Systems. The 510(k) number is K900740.

When did SPECIMEX DC receive FDA 510(k) clearance?

SPECIMEX DC received FDA 510(k) clearance on 1990-05-11, under 510(k) number K900740.

Who is the listed applicant for SPECIMEX DC?

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

What is the FDA product code for SPECIMEX DC?

The FDA product code for SPECIMEX DC is GXZ.

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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.

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