ENEO TOTALE (Model: ENEOT947)
K-Number: K213841 · 2022-01-06
ApplicantPremier North America, Inc.
Decision Date2022-01-06
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
ENEO TOTALE (Model: ENEOT947) is a medical device manufactured by Premier North America, Inc.. It received FDA 510(k) clearance on 2022-01-06 under approval number K213841. 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 ENEO TOTALE (Model: ENEOT947)?
ENEO TOTALE (Model: ENEOT947) is a medical device that received FDA 510(k) clearance on 2022-01-06. It is manufactured by Premier North America, Inc.. The 510(k) number is K213841.
When was ENEO TOTALE (Model: ENEOT947) approved by the FDA?
ENEO TOTALE (Model: ENEOT947) received FDA 510(k) clearance on 2022-01-06, under approval number K213841.
What company makes ENEO TOTALE (Model: ENEOT947)?
ENEO TOTALE (Model: ENEOT947) is manufactured by Premier North America, Inc..
What is the FDA product code for ENEO TOTALE (Model: ENEOT947)?
The FDA product code for ENEO TOTALE (Model: ENEOT947) 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.