Insulia Bolus Companion
K-Number: K232451 · 2023-12-12
ApplicantVoluntis Sa.
Decision Date2023-12-12
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Insulia Bolus Companion is a medical device manufactured by Voluntis Sa.. It received FDA 510(k) clearance on 2023-12-12 under approval number K232451. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Insulia Bolus Companion?
Insulia Bolus Companion is a medical device that received FDA 510(k) clearance on 2023-12-12. It is manufactured by Voluntis Sa.. The 510(k) number is K232451.
When was Insulia Bolus Companion approved by the FDA?
Insulia Bolus Companion received FDA 510(k) clearance on 2023-12-12, under approval number K232451.
What company makes Insulia Bolus Companion?
Insulia Bolus Companion is manufactured by Voluntis Sa..
What is the FDA product code for Insulia Bolus Companion?
The FDA product code for Insulia Bolus Companion is NDC.
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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.