510(k) K180865
K180865 is an FDA 510(k) premarket notification submitted by Zmi Electronics , Ltd. for the device "ZMI Self-Adhesive Electrodes". The FDA issued a decision of Substantially Equivalent on June 28, 2018. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Zmi Electronics , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 2018
- Date Received
- April 2, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Cutaneous
- Device Class
- Class II
- Regulation Number
- 882.1320
- Review Panel
- NE
- Submission Type