Decision Date2025-04-25
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
contact forte Alpha is the device name listed in this FDA 510(k) record. The listed applicant is Bhm-Tech Produktionsgesellschaft Mbh. It received FDA 510(k) clearance on 2025-04-25 under 510(k) number K243041. The device is classified under product code LXB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the contact forte Alpha?
contact forte Alpha is a medical device that received FDA 510(k) clearance on 2025-04-25. The listed applicant is Bhm-Tech Produktionsgesellschaft Mbh. The 510(k) number is K243041.
When did contact forte Alpha receive FDA 510(k) clearance?
contact forte Alpha received FDA 510(k) clearance on 2025-04-25, under 510(k) number K243041.
Who is the listed applicant for contact forte Alpha?
The FDA 510(k) record lists Bhm-Tech Produktionsgesellschaft Mbh as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for contact forte Alpha?
The FDA product code for contact forte Alpha is LXB.
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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.