TrueFit Bolus; TrueFlex Bolus
K-Number: K243057 · 2024-10-23
ApplicantAdaptiiv Medical Technologies, Inc.
Decision Date2024-10-23
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
TrueFit Bolus; TrueFlex Bolus is a medical device manufactured by Adaptiiv Medical Technologies, Inc.. It received FDA 510(k) clearance on 2024-10-23 under approval number K243057. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TrueFit Bolus; TrueFlex Bolus?
TrueFit Bolus; TrueFlex Bolus is a medical device that received FDA 510(k) clearance on 2024-10-23. It is manufactured by Adaptiiv Medical Technologies, Inc.. The 510(k) number is K243057.
When was TrueFit Bolus; TrueFlex Bolus approved by the FDA?
TrueFit Bolus; TrueFlex Bolus received FDA 510(k) clearance on 2024-10-23, under approval number K243057.
What company makes TrueFit Bolus; TrueFlex Bolus?
TrueFit Bolus; TrueFlex Bolus is manufactured by Adaptiiv Medical Technologies, Inc..
What is the FDA product code for TrueFit Bolus; TrueFlex Bolus?
The FDA product code for TrueFit Bolus; TrueFlex Bolus is MUJ.
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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.