The following data is part of a premarket notification filed by Ndi Medical, Llc with the FDA for Checkpoint With Accustim Technology.
| Device ID | K061365 |
| 510k Number | K061365 |
| Device Name: | CHECKPOINT WITH ACCUSTIM TECHNOLOGY |
| Classification | Stimulator, Nerve |
| Applicant | NDI MEDICAL, LLC ONE CHAGRIN HIGHLANDS 2000 AUBURN DRIVE, SUITE 320 Cleveland, OH 44122 |
| Contact | Julie Grill |
| Correspondent | Julie Grill NDI MEDICAL, LLC ONE CHAGRIN HIGHLANDS 2000 AUBURN DRIVE, SUITE 320 Cleveland, OH 44122 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-16 |
| Decision Date | 2006-07-12 |
| Summary: | summary |