Biotronik, Inc. · Class III · Cleared Jul 22, 1998
| K-number | K981083 |
| Device name | RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000 |
| Applicant | Biotronik, Inc. |
| Product code | DTB |
| Device class | Class III |
| Decision date | Jul 22, 1998 |
| Decision | Substantially Equivalent - Subject to Tracking Reg. |
| Regulation | 870.3680 |
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