The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Era 3000 Pacing System Analyzer.
| Device ID | K042708 |
| 510k Number | K042708 |
| Device Name: | ERA 3000 PACING SYSTEM ANALYZER |
| Classification | Pulse-generator, Pacemaker, External |
| Applicant | BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Contact | Jon Brumbaugh |
| Correspondent | Jon Brumbaugh BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Product Code | DTE |
| CFR Regulation Number | 870.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-30 |
| Decision Date | 2004-10-20 |
| Summary: | summary |