510(k) K150005
K150005 is an FDA 510(k) premarket notification submitted by Ndi Medical, LLC for the device "Checkpoint, Checkpoint Head & Neck". The FDA issued a decision of Substantially Equivalent on February 19, 2015. 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
- February 19, 2015
- Date Received
- January 2, 2015
- Clearance Type
- Special
- 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