Decision Date2025-10-01
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
E Blator is the device name listed in this FDA 510(k) record. The listed applicant is New Deantronics Taiwan , Ltd.. It received FDA 510(k) clearance on 2025-10-01 under 510(k) number K251899. 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 E Blator?
E Blator is a medical device that received FDA 510(k) clearance on 2025-10-01. The listed applicant is New Deantronics Taiwan , Ltd.. The 510(k) number is K251899.
When did E Blator receive FDA 510(k) clearance?
E Blator received FDA 510(k) clearance on 2025-10-01, under 510(k) number K251899.
Who is the listed applicant for E Blator?
The FDA 510(k) record lists New Deantronics Taiwan , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for E Blator?
The FDA product code for E Blator 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.