Greiner Holdex
K-Number: K160532 · 2016-11-03
ApplicantGreiner Bio-One Na, Inc.
Decision Date2016-11-03
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Greiner Holdex is a medical device manufactured by Greiner Bio-One Na, Inc.. It received FDA 510(k) clearance on 2016-11-03 under approval number K160532. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Greiner Holdex?
Greiner Holdex is a medical device that received FDA 510(k) clearance on 2016-11-03. It is manufactured by Greiner Bio-One Na, Inc.. The 510(k) number is K160532.
When was Greiner Holdex approved by the FDA?
Greiner Holdex received FDA 510(k) clearance on 2016-11-03, under approval number K160532.
What company makes Greiner Holdex?
Greiner Holdex is manufactured by Greiner Bio-One Na, Inc..
What is the FDA product code for Greiner Holdex?
The FDA product code for Greiner Holdex is FMI.
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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.