FlexBand Plus
K-Number: K192112 · 2019-09-27
ApplicantInternational Life Sciences
Decision Date2019-09-27
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
FlexBand Plus is a medical device manufactured by International Life Sciences. It received FDA 510(k) clearance on 2019-09-27 under approval number K192112. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FlexBand Plus?
FlexBand Plus is a medical device that received FDA 510(k) clearance on 2019-09-27. It is manufactured by International Life Sciences. The 510(k) number is K192112.
When was FlexBand Plus approved by the FDA?
FlexBand Plus received FDA 510(k) clearance on 2019-09-27, under approval number K192112.
What company makes FlexBand Plus?
FlexBand Plus is manufactured by International Life Sciences.
What is the FDA product code for FlexBand Plus?
The FDA product code for FlexBand Plus is FTL.
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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.