The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Ems System 6000 E.s.u..
| Device ID | K871435 |
| 510k Number | K871435 |
| Device Name: | BARD EMS SYSTEM 6000 E.S.U. |
| Classification | Apparatus, Electrosurgical |
| Applicant | C.R. BARD, INC. 111 SPRING ST. Murray Hill, NJ 07974 |
| Contact | Catherine V Beath |
| Correspondent | Catherine V Beath C.R. BARD, INC. 111 SPRING ST. Murray Hill, NJ 07974 |
| Product Code | HAM |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-13 |
| Decision Date | 1987-05-11 |