510(k) K181070
K181070 is an FDA 510(k) premarket notification submitted by Andon Health Co, Ltd. for the device "iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)". The FDA issued a decision of Substantially Equivalent on February 1, 2019. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Andon Health Co, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 2019
- Date Received
- April 23, 2018
- 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