The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Arox 45-jbp; Arox 53-jbp; Merox 45-jbp; Merox 53-jbp.
| Device ID | K023099 |
| 510k Number | K023099 |
| Device Name: | AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP |
| Classification | Permanent Pacemaker Electrode |
| 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 | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-18 |
| Decision Date | 2002-10-18 |
| Summary: | summary |