Procellera
K-Number: K160783 · 2016-09-07
ApplicantVomaris Innovations, Inc.
Decision Date2016-09-07
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
Procellera is a medical device manufactured by Vomaris Innovations, Inc.. It received FDA 510(k) clearance on 2016-09-07 under approval number K160783. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Procellera?
Procellera is a medical device that received FDA 510(k) clearance on 2016-09-07. It is manufactured by Vomaris Innovations, Inc.. The 510(k) number is K160783.
When was Procellera approved by the FDA?
Procellera received FDA 510(k) clearance on 2016-09-07, under approval number K160783.
What company makes Procellera?
Procellera is manufactured by Vomaris Innovations, Inc..
What is the FDA product code for Procellera?
The FDA product code for Procellera is FRO. This falls under the Anesthesiology category.
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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.