Decision Date2019-07-10
Product CodeNXO
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
Calprest, EasyCal is a medical device manufactured by Eurospital S.P.A.. It received FDA 510(k) clearance on 2019-07-10 under approval number K191589. The device is classified under product code NXO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Calprest, EasyCal?
Calprest, EasyCal is a medical device that received FDA 510(k) clearance on 2019-07-10. It is manufactured by Eurospital S.P.A.. The 510(k) number is K191589.
When was Calprest, EasyCal approved by the FDA?
Calprest, EasyCal received FDA 510(k) clearance on 2019-07-10, under approval number K191589.
What company makes Calprest, EasyCal?
Calprest, EasyCal is manufactured by Eurospital S.P.A..
What is the FDA product code for Calprest, EasyCal?
The FDA product code for Calprest, EasyCal is NXO.
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Official Source
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