SmartByte Device
K-Number: K171165 · 2017-05-18
ApplicantScientific Intake
Decision Date2017-05-18
Product CodeONY
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
SmartByte Device is a medical device manufactured by Scientific Intake. It received FDA 510(k) clearance on 2017-05-18 under approval number K171165. The device is classified under product code ONY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SmartByte Device?
SmartByte Device is a medical device that received FDA 510(k) clearance on 2017-05-18. It is manufactured by Scientific Intake. The 510(k) number is K171165.
When was SmartByte Device approved by the FDA?
SmartByte Device received FDA 510(k) clearance on 2017-05-18, under approval number K171165.
What company makes SmartByte Device?
SmartByte Device is manufactured by Scientific Intake.
What is the FDA product code for SmartByte Device?
The FDA product code for SmartByte Device is ONY.
Other Devices by Scientific Intake
Related Devices (Code: ONY)
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.