510(k) K992869
K992869 is an FDA 510(k) premarket notification submitted by Xomed, Inc. for the device "XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE". The FDA issued a decision of Substantially Equivalent on October 7, 1999. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Xomed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 7, 1999
- Date Received
- August 25, 1999
- 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