510(k) K092292
K092292 is an FDA 510(k) premarket notification submitted by Ndi Medical, LLC for the device "CHECKPOINT". The FDA issued a decision of Substantially Equivalent on October 28, 2009. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Ndi Medical, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 2009
- Date Received
- July 29, 2009
- 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