510(k) K112426
K112426 is an FDA 510(k) premarket notification submitted by Xian Friendship Medical Electronics Co., Ltd. for the device "XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES". The FDA issued a decision of Substantially Equivalent on Apr 2, 2012. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Xian Friendship Medical Electronics Co., Ltd. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 2, 2012
- Date Received
- Aug 23, 2011
- Clearance Type
- Traditional
- 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
- 510(k)