Parcus Synd-EZ Ti
K-Number: K191783 · 2019-10-09
ApplicantParcus Medical, LLC
Decision Date2019-10-09
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Parcus Synd-EZ Ti is a medical device manufactured by Parcus Medical, LLC. It received FDA 510(k) clearance on 2019-10-09 under approval number K191783. 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 Parcus Synd-EZ Ti?
Parcus Synd-EZ Ti is a medical device that received FDA 510(k) clearance on 2019-10-09. It is manufactured by Parcus Medical, LLC. The 510(k) number is K191783.
When was Parcus Synd-EZ Ti approved by the FDA?
Parcus Synd-EZ Ti received FDA 510(k) clearance on 2019-10-09, under approval number K191783.
What company makes Parcus Synd-EZ Ti?
Parcus Synd-EZ Ti is manufactured by Parcus Medical, LLC.
What is the FDA product code for Parcus Synd-EZ Ti?
The FDA product code for Parcus Synd-EZ Ti 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.