Decision Date1998-08-05
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
UM-150A is the device name listed in this FDA 510(k) record. The listed applicant is Umeco Union Medical Engineering. It received FDA 510(k) clearance on 1998-08-05 under 510(k) number K981908. 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 UM-150A?
UM-150A is a medical device that received FDA 510(k) clearance on 1998-08-05. The listed applicant is Umeco Union Medical Engineering. The 510(k) number is K981908.
When did UM-150A receive FDA 510(k) clearance?
UM-150A received FDA 510(k) clearance on 1998-08-05, under 510(k) number K981908.
Who is the listed applicant for UM-150A?
The FDA 510(k) record lists Umeco Union Medical Engineering as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for UM-150A?
The FDA product code for UM-150A is GEI.
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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.