The following data is part of a premarket notification filed by Biotronik Sales, Inc. with the FDA for Era-20.
| Device ID | K853194 |
| 510k Number | K853194 |
| Device Name: | ERA-20 |
| Classification | Pulse-generator, Pacemaker, External |
| Applicant | BIOTRONIK SALES, INC. POST OFFICE BOX 1988 Lake Oswego, OR 97034 |
| Contact | Cawthon |
| Correspondent | Cawthon BIOTRONIK SALES, INC. POST OFFICE BOX 1988 Lake Oswego, OR 97034 |
| Product Code | DTE |
| CFR Regulation Number | 870.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-30 |
| Decision Date | 1987-03-11 |