BluePro
K-Number: K162192 · 2016-12-15
ApplicantBluesom
Decision Date2016-12-15
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BluePro is a medical device manufactured by Bluesom. It received FDA 510(k) clearance on 2016-12-15 under approval number K162192. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BluePro?
BluePro is a medical device that received FDA 510(k) clearance on 2016-12-15. It is manufactured by Bluesom. The 510(k) number is K162192.
When was BluePro approved by the FDA?
BluePro received FDA 510(k) clearance on 2016-12-15, under approval number K162192.
What company makes BluePro?
BluePro is manufactured by Bluesom.
What is the FDA product code for BluePro?
The FDA product code for BluePro is LRK.
Related Devices (Code: LRK)
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.