The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Modification To Era 300 Dual Chamber Pacing System Analyzer.
| Device ID | K033613 |
| 510k Number | K033613 |
| Device Name: | MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER |
| Classification | Tester, Pacemaker Electrode Function |
| 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 | DTA |
| Subsequent Product Code | DTC |
| Subsequent Product Code | DTE |
| CFR Regulation Number | 870.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-17 |
| Decision Date | 2003-12-08 |
| Summary: | summary |