Smart Set
K-Number: K151250 · 2016-06-07
ApplicantTop Spins, Inc.
Decision Date2016-06-07
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Smart Set is a medical device manufactured by Top Spins, Inc.. It received FDA 510(k) clearance on 2016-06-07 under approval number K151250. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Smart Set?
Smart Set is a medical device that received FDA 510(k) clearance on 2016-06-07. It is manufactured by Top Spins, Inc.. The 510(k) number is K151250.
When was Smart Set approved by the FDA?
Smart Set received FDA 510(k) clearance on 2016-06-07, under approval number K151250.
What company makes Smart Set?
Smart Set is manufactured by Top Spins, Inc..
What is the FDA product code for Smart Set?
The FDA product code for Smart Set is FPA.
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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.