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 the device name listed in this FDA 510(k) record. The listed applicant is Scientific Intake. It received FDA 510(k) clearance on 2017-05-18 under 510(k) 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. The listed applicant is Scientific Intake. The 510(k) number is K171165.
When did SmartByte Device receive FDA 510(k) clearance?
SmartByte Device received FDA 510(k) clearance on 2017-05-18, under 510(k) number K171165.
Who is the listed applicant for SmartByte Device?
The FDA 510(k) record lists Scientific Intake as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SmartByte Device?
The FDA product code for SmartByte Device is 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.