510(k) K063560
K063560 is an FDA 510(k) premarket notification submitted by Wr Medical Electronics Co. for the device "HILGER DUAL-STIM NERVE STIMULATOR". The FDA issued a decision of Substantially Equivalent on January 5, 2007. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Wr Medical Electronics Co. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 5, 2007
- Date Received
- November 28, 2006
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve
- Device Class
- Class II
- Regulation Number
- 874.1820
- Review Panel
- EN
- Submission Type