Compact II
K-Number: K251083 · 2025-09-12
ApplicantEnraf-Nonius, B.V.
Decision Date2025-09-12
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Compact II is a medical device manufactured by Enraf-Nonius, B.V.. It received FDA 510(k) clearance on 2025-09-12 under approval number K251083. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Compact II?
Compact II is a medical device that received FDA 510(k) clearance on 2025-09-12. It is manufactured by Enraf-Nonius, B.V.. The 510(k) number is K251083.
When was Compact II approved by the FDA?
Compact II received FDA 510(k) clearance on 2025-09-12, under approval number K251083.
What company makes Compact II?
Compact II is manufactured by Enraf-Nonius, B.V..
What is the FDA product code for Compact II?
The FDA product code for Compact II is IPF.
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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.