BluePro
K-Number: K162192 · 2016-12-15
ApplicantBluesom
Decision Date2016-12-15
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BluePro is the device name listed in this FDA 510(k) record. The listed applicant is Bluesom. It received FDA 510(k) clearance on 2016-12-15 under 510(k) 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. The listed applicant is Bluesom. The 510(k) number is K162192.
When did BluePro receive FDA 510(k) clearance?
BluePro received FDA 510(k) clearance on 2016-12-15, under 510(k) number K162192.
Who is the listed applicant for BluePro?
The FDA 510(k) record lists Bluesom as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BluePro?
The FDA product code for BluePro is LRK.
Related Devices (Code: LRK)
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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.