Elos Accurate Hybrid Base
K-Number: K251497 · 2025-10-16
ApplicantElos Medtech Pinol A/S
Decision Date2025-10-16
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Elos Accurate Hybrid Base is a medical device manufactured by Elos Medtech Pinol A/S. It received FDA 510(k) clearance on 2025-10-16 under approval number K251497. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Elos Accurate Hybrid Base?
Elos Accurate Hybrid Base is a medical device that received FDA 510(k) clearance on 2025-10-16. It is manufactured by Elos Medtech Pinol A/S. The 510(k) number is K251497.
When was Elos Accurate Hybrid Base approved by the FDA?
Elos Accurate Hybrid Base received FDA 510(k) clearance on 2025-10-16, under approval number K251497.
What company makes Elos Accurate Hybrid Base?
Elos Accurate Hybrid Base is manufactured by Elos Medtech Pinol A/S.
What is the FDA product code for Elos Accurate Hybrid Base?
The FDA product code for Elos Accurate Hybrid Base is NHA.
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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.