Elite SPK, Compasso, Elite SPK Kit
K-Number: K160500 · 2016-04-20
ApplicantNcs Lab Srl
Decision Date2016-04-20
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Elite SPK, Compasso, Elite SPK Kit is a medical device manufactured by Ncs Lab Srl. It received FDA 510(k) clearance on 2016-04-20 under approval number K160500. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Elite SPK, Compasso, Elite SPK Kit?
Elite SPK, Compasso, Elite SPK Kit is a medical device that received FDA 510(k) clearance on 2016-04-20. It is manufactured by Ncs Lab Srl. The 510(k) number is K160500.
When was Elite SPK, Compasso, Elite SPK Kit approved by the FDA?
Elite SPK, Compasso, Elite SPK Kit received FDA 510(k) clearance on 2016-04-20, under approval number K160500.
What company makes Elite SPK, Compasso, Elite SPK Kit?
Elite SPK, Compasso, Elite SPK Kit is manufactured by Ncs Lab Srl.
What is the FDA product code for Elite SPK, Compasso, Elite SPK Kit?
The FDA product code for Elite SPK, Compasso, Elite SPK Kit is MBI.
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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.