The following data is part of a premarket notification filed by Ness-neuromuscular Electrical Stimulation Systems with the FDA for Modification To:ness L300.
| Device ID | K080219 |
| 510k Number | K080219 |
| Device Name: | MODIFICATION TO:NESS L300 |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS 25103 RYE CANYON LOOP Valencia, CA 91355 |
| Contact | Evan Rosenfeld |
| Correspondent | Evan Rosenfeld NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS 25103 RYE CANYON LOOP Valencia, CA 91355 |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-29 |
| Decision Date | 2008-02-28 |
| Summary: | summary |