The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Neuro Pulse Ii,iii.
| Device ID | K971143 |
| 510k Number | K971143 |
| Device Name: | NEURO PULSE II,III |
| Classification | Stimulator, Nerve |
| Applicant | AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 |
| Contact | J. R Saron |
| Correspondent | J. R Saron AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-28 |
| Decision Date | 1997-06-06 |