The following data is part of a premarket notification filed by Bard Electro Medical Systems, Inc. with the FDA for Bard Ems Systems 3400 & 4400 & Dual Pad Electrode.
| Device ID | K883762 |
| 510k Number | K883762 |
| Device Name: | BARD EMS SYSTEMS 3400 & 4400 & DUAL PAD ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BARD ELECTRO MEDICAL SYSTEMS, INC. 11011 EAST PEAKVIEW AVE. Englewood, CO 80111 |
| Contact | Peter J Scott |
| Correspondent | Peter J Scott BARD ELECTRO MEDICAL SYSTEMS, INC. 11011 EAST PEAKVIEW AVE. Englewood, CO 80111 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-06 |
| Decision Date | 1988-09-27 |