TBI
K-Number: K232669 · 2023-09-29
ApplicantAbbott Laboratories
Decision Date2023-09-29
Product CodeQAT
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
TBI is a medical device manufactured by Abbott Laboratories. It received FDA 510(k) clearance on 2023-09-29 under approval number K232669. The device is classified under product code QAT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TBI?
TBI is a medical device that received FDA 510(k) clearance on 2023-09-29. It is manufactured by Abbott Laboratories. The 510(k) number is K232669.
When was TBI approved by the FDA?
TBI received FDA 510(k) clearance on 2023-09-29, under approval number K232669.
What company makes TBI?
TBI is manufactured by Abbott Laboratories.
What is the FDA product code for TBI?
The FDA product code for TBI is QAT.
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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.