510(k) K163159
K163159 is an FDA 510(k) premarket notification submitted by Labstyle Innovations, Ltd. for the device "Dario Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on July 19, 2017. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Labstyle Innovations, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 2017
- Date Received
- November 10, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Blood Glucose, Over The Counter
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type