The following data is part of a premarket notification filed by Instromedix, Inc. with the FDA for Ekg Transmitter Model 5134.
| Device ID | K842051 |
| 510k Number | K842051 |
| Device Name: | EKG TRANSMITTER MODEL 5134 |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | INSTROMEDIX, INC. 10950 SW FIFTH AVE. Beaverton, OR 97005 |
| Contact | Semler |
| Correspondent | Semler INSTROMEDIX, INC. 10950 SW FIFTH AVE. Beaverton, OR 97005 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-22 |
| Decision Date | 1985-03-01 |