FDA 510(k)

UC IMU A

K-Number: K904125 · 1990-09-24

Decision Date1990-09-24

Product CodeDER

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

UC IMU A is the device name listed in this FDA 510(k) record. The listed applicant is Eucardio Laboratory, Inc.. It received FDA 510(k) clearance on 1990-09-24 under 510(k) number K904125. The device is classified under product code DER. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UC IMU A?

UC IMU A is a medical device that received FDA 510(k) clearance on 1990-09-24. The listed applicant is Eucardio Laboratory, Inc.. The 510(k) number is K904125.

When did UC IMU A receive FDA 510(k) clearance?

UC IMU A received FDA 510(k) clearance on 1990-09-24, under 510(k) number K904125.

Who is the listed applicant for UC IMU A?

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

What is the FDA product code for UC IMU A?

The FDA product code for UC IMU A is DER.

Other records listing Eucardio Laboratory, Inc. as applicant

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.

K942464UC QIK 1-STEP HCG TEST K926500UC QIK PREGNANCY TEST K904137UC IMU B

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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.