The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Pikos 01, Pikos E01, Pikos 01-b, Pikos E01-b, Pikos 01-a, Pikos E01-a.
| Device ID | K993434 |
| 510k Number | K993434 |
| Device Name: | PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A |
| Classification | Implantable Pacemaker Pulse-generator |
| 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 | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-12 |
| Decision Date | 1999-11-10 |
| Summary: | summary |