Zavation IBF
K-Number: K162206 · 2017-04-04
ApplicantZavation, LLC
Decision Date2017-04-04
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Zavation IBF is a medical device manufactured by Zavation, LLC. It received FDA 510(k) clearance on 2017-04-04 under approval number K162206. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Zavation IBF?
Zavation IBF is a medical device that received FDA 510(k) clearance on 2017-04-04. It is manufactured by Zavation, LLC. The 510(k) number is K162206.
When was Zavation IBF approved by the FDA?
Zavation IBF received FDA 510(k) clearance on 2017-04-04, under approval number K162206.
What company makes Zavation IBF?
Zavation IBF is manufactured by Zavation, LLC.
What is the FDA product code for Zavation IBF?
The FDA product code for Zavation IBF is MAX.
Other Devices by Zavation, LLC
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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.