Avologi ENEO
K-Number: K181659 · 2018-07-26
ApplicantPremier North America, Inc.
Decision Date2018-07-26
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Avologi ENEO is a medical device manufactured by Premier North America, Inc.. It received FDA 510(k) clearance on 2018-07-26 under approval number K181659. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Avologi ENEO?
Avologi ENEO is a medical device that received FDA 510(k) clearance on 2018-07-26. It is manufactured by Premier North America, Inc.. The 510(k) number is K181659.
When was Avologi ENEO approved by the FDA?
Avologi ENEO received FDA 510(k) clearance on 2018-07-26, under approval number K181659.
What company makes Avologi ENEO?
Avologi ENEO is manufactured by Premier North America, Inc..
What is the FDA product code for Avologi ENEO?
The FDA product code for Avologi ENEO is OHS.
Other Devices by Premier North America, Inc.
Related Devices (Code: OHS)
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.