510(k) K090889
K090889 is an FDA 510(k) premarket notification submitted by Emsi for the device "EMSI GARMENT ELECTRODES". The FDA issued a decision of Substantially Equivalent on Dec 4, 2009. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Emsi has 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 4, 2009
- Date Received
- Mar 31, 2009
- 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)