The following data is part of a premarket notification filed by Biotronik, Gmbh & Co. with the FDA for Pikos 01-a And Pikos E01-a Implantable Pacemaker.
| Device ID | K923026 |
| 510k Number | K923026 |
| Device Name: | PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | BIOTRONIK, GMBH & CO. 6024 SOUTHWEST JEAN RD. UNIT B4 Lake Oswego, OR 97035 -5369 |
| Contact | Stephen K Deol |
| Correspondent | Stephen K Deol BIOTRONIK, GMBH & CO. 6024 SOUTHWEST JEAN RD. UNIT B4 Lake Oswego, OR 97035 -5369 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-23 |
| Decision Date | 1993-08-19 |