The following data is part of a premarket notification filed by Ndi Medical, Llc with the FDA for Checkpoint, Checkpoint Head & Neck.
| Device ID | K150005 |
| 510k Number | K150005 |
| Device Name: | Checkpoint, Checkpoint Head & Neck |
| Classification | Stimulator, Nerve |
| Applicant | NDI Medical, LLC 22901 Millcreek Boulevard, Suite 110 Cleveland, OH 44122 |
| Contact | Robert Rogers |
| Correspondent | Robert Rogers NDI Medical, LLC 22901 Millcreek Boulevard, Suite 110 Cleveland, OH 44122 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-02 |
| Decision Date | 2015-02-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B13093941 | K150005 | 000 |