The following data is part of a premarket notification filed by Instromedix, Inc. with the FDA for Blood-pressure Ecg Transmitter.
| Device ID | K844310 |
| 510k Number | K844310 |
| Device Name: | BLOOD-PRESSURE ECG TRANSMITTER |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| 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 | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-06 |
| Decision Date | 1985-04-18 |