SmartByte Device— 510(k) K171165
Substantially EquivalentScientific Intake
FDA 510(k) clearance K171165 for SmartByte Device, Substantially Equivalent on 2017-05-18. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Lawrence, MA, US
Recent devices under product code ONY
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