Sensor Monitored Alimentary Restriction Therapy (SMART) Device— 510(k) DEN150033

Name: FDA 510(k) clearance DEN150033
Creator: U.S. Food and Drug Administration
Published: 2016-09-26

Unknown

Scientific Intake

FDA 510(k) clearance DEN150033 for Sensor Monitored Alimentary Restriction Therapy (SMART) Device, Unknown on 2016-09-26. Applicant: Scientific Intake. Device class: 2.

Clearance details

Applicant: Scientific Intake
Product code: Code ONY
Device class: Class 2
Regulation: 21 CFR 876.5981
Advisory panel: Gastroenterology, Urology
Date received: 2015-07-31
Decision date: 2016-09-26
Decision: Unknown
Clearance type: Direct
Location: Atlanta, GA, US

View on FDA.gov ↗

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