Parcus ATLAS
K-Number: K190375 · 2019-04-24
ApplicantParcus Medical, LLC
Decision Date2019-04-24
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Parcus ATLAS is a medical device manufactured by Parcus Medical, LLC. It received FDA 510(k) clearance on 2019-04-24 under approval number K190375. 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 ATLAS?
Parcus ATLAS is a medical device that received FDA 510(k) clearance on 2019-04-24. It is manufactured by Parcus Medical, LLC. The 510(k) number is K190375.
When was Parcus ATLAS approved by the FDA?
Parcus ATLAS received FDA 510(k) clearance on 2019-04-24, under approval number K190375.
What company makes Parcus ATLAS?
Parcus ATLAS is manufactured by Parcus Medical, LLC.
What is the FDA product code for Parcus ATLAS?
The FDA product code for Parcus ATLAS 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.