The following data is part of a premarket notification filed by Pantheon Research with the FDA for Pantheon Electrostimulator.
| Device ID | K133980 |
| 510k Number | K133980 |
| Device Name: | PANTHEON ELECTROSTIMULATOR |
| Classification | Stimulator, Electro-acupuncture |
| Applicant | PANTHEON RESEARCH 1468 HARWELL AVE Crofton, MD 21114 |
| Contact | Yolanda Smith |
| Correspondent | Yolanda Smith PANTHEON RESEARCH 1468 HARWELL AVE Crofton, MD 21114 |
| Product Code | BWK |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-27 |
| Decision Date | 2014-11-07 |
| Summary: | summary |