iCEM Universal Plus
K-Number: K254063 · 2025-12-19
ApplicantKulzer, LLC
Decision Date2025-12-19
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
iCEM Universal Plus is a medical device manufactured by Kulzer, LLC. It received FDA 510(k) clearance on 2025-12-19 under approval number K254063. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the iCEM Universal Plus?
iCEM Universal Plus is a medical device that received FDA 510(k) clearance on 2025-12-19. It is manufactured by Kulzer, LLC. The 510(k) number is K254063.
When was iCEM Universal Plus approved by the FDA?
iCEM Universal Plus received FDA 510(k) clearance on 2025-12-19, under approval number K254063.
What company makes iCEM Universal Plus?
iCEM Universal Plus is manufactured by Kulzer, LLC.
What is the FDA product code for iCEM Universal Plus?
The FDA product code for iCEM Universal Plus is EMA.
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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.