The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Synox Sx 53-bp, Sx 60-bp, Sx 45-jbp, Sx 53-jbp , Models 120 444, 119 684, 120 438 And 120 143.
| Device ID | K980869 |
| 510k Number | K980869 |
| Device Name: | SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143 |
| Classification | Permanent Pacemaker Electrode |
| Applicant | BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Contact | David Makanani |
| Correspondent | David Makanani BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-06 |
| Decision Date | 1998-09-10 |
| Summary: | summary |