510(k) K173186
K173186 is an FDA 510(k) premarket notification submitted by Everyway Medical Instruments Co.,Ltd for the device "S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D". The FDA issued a decision of Substantially Equivalent on February 28, 2018. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Everyway Medical Instruments Co.,Ltd has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 2018
- Date Received
- October 2, 2017
- Clearance Type
- Special
- 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