BLU TOTALE (Model: ENEOB852)
K-Number: K232656 · 2023-11-14
ApplicantPremier North America, Inc.
Decision Date2023-11-14
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
BLU TOTALE (Model: ENEOB852) is a medical device manufactured by Premier North America, Inc.. It received FDA 510(k) clearance on 2023-11-14 under approval number K232656. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BLU TOTALE (Model: ENEOB852)?
BLU TOTALE (Model: ENEOB852) is a medical device that received FDA 510(k) clearance on 2023-11-14. It is manufactured by Premier North America, Inc.. The 510(k) number is K232656.
When was BLU TOTALE (Model: ENEOB852) approved by the FDA?
BLU TOTALE (Model: ENEOB852) received FDA 510(k) clearance on 2023-11-14, under approval number K232656.
What company makes BLU TOTALE (Model: ENEOB852)?
BLU TOTALE (Model: ENEOB852) is manufactured by Premier North America, Inc..
What is the FDA product code for BLU TOTALE (Model: ENEOB852)?
The FDA product code for BLU TOTALE (Model: ENEOB852) is OLP.
Other Devices by Premier North America, Inc.
Related Devices (Code: OLP)
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.