FDA 510(k)

E Blator

K-Number: K251899 · 2025-10-01

Decision Date2025-10-01

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

E Blator is a medical device manufactured by New Deantronics Taiwan , Ltd.. It received FDA 510(k) clearance on 2025-10-01 under approval 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. It is manufactured by New Deantronics Taiwan , Ltd.. The 510(k) number is K251899.

When was E Blator approved by the FDA?

E Blator received FDA 510(k) clearance on 2025-10-01, under approval number K251899.

What company makes E Blator?

E Blator is manufactured by New Deantronics Taiwan , Ltd..

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.