510(k) K083302
K083302 is an FDA 510(k) premarket notification submitted by Everyway Medical Instruments Co.,Ltd for the device "LIFECARE ELECTRODES". The FDA issued a decision of Substantially Equivalent on Aug 3, 2009. 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 28 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 3, 2009
- Date Received
- Nov 10, 2008
- 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
- 510(k)