Nimbl (model PD08-N1)
K-Number: K234155 · 2024-06-21
ApplicantTactile Medical
Decision Date2024-06-21
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Nimbl (model PD08-N1) is a medical device manufactured by Tactile Medical. It received FDA 510(k) clearance on 2024-06-21 under approval number K234155. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Nimbl (model PD08-N1)?
Nimbl (model PD08-N1) is a medical device that received FDA 510(k) clearance on 2024-06-21. It is manufactured by Tactile Medical. The 510(k) number is K234155.
When was Nimbl (model PD08-N1) approved by the FDA?
Nimbl (model PD08-N1) received FDA 510(k) clearance on 2024-06-21, under approval number K234155.
What company makes Nimbl (model PD08-N1)?
Nimbl (model PD08-N1) is manufactured by Tactile Medical.
What is the FDA product code for Nimbl (model PD08-N1)?
The FDA product code for Nimbl (model PD08-N1) is JOW.
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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.