The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Sx 53/15-bp, Model 124 853, Sx 60/15-bp, Model 124 854.
| Device ID | K991169 |
| 510k Number | K991169 |
| Device Name: | SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854 |
| 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 | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-07 |
| Decision Date | 1999-07-01 |
| Summary: | summary |