The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Pikos E 01-b.
| Device ID | K941937 |
| 510k Number | K941937 |
| Device Name: | PIKOS E 01-B |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Contact | Lauren L Foote Christensen |
| Correspondent | Lauren L Foote Christensen BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Se - Postmarket Surveillance Required (SESP) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-21 |
| Decision Date | 1994-08-30 |