Normandy VBR System
K-Number: K191423 · 2019-08-06
ApplicantZavation Medical Products, LLC
Decision Date2019-08-06
Product CodePLR
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Normandy VBR System is a medical device manufactured by Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2019-08-06 under approval number K191423. The device is classified under product code PLR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Normandy VBR System?
Normandy VBR System is a medical device that received FDA 510(k) clearance on 2019-08-06. It is manufactured by Zavation Medical Products, LLC. The 510(k) number is K191423.
When was Normandy VBR System approved by the FDA?
Normandy VBR System received FDA 510(k) clearance on 2019-08-06, under approval number K191423.
What company makes Normandy VBR System?
Normandy VBR System is manufactured by Zavation Medical Products, LLC.
What is the FDA product code for Normandy VBR System?
The FDA product code for Normandy VBR System is PLR.
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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.