The following data is part of a premarket notification filed by Biotronik, Gmbh & Co. with the FDA for Hpm 40 Heart Pacemaker Monitor.
| Device ID | K922742 |
| 510k Number | K922742 |
| Device Name: | HPM 40 HEART PACEMAKER MONITOR |
| Classification | Analyzer, Pacemaker Generator Function, Indirect |
| 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 | KRE |
| CFR Regulation Number | 870.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-08 |
| Decision Date | 1993-03-18 |