The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Nanos, Pikos 01/e01, 01-a, E01-b, Lp 01/lp E01.
| Device ID | K952328 |
| 510k Number | K952328 |
| Device Name: | NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 |
| 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 Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-18 |
| Decision Date | 1995-09-29 |