The following data is part of a premarket notification filed by Sensormedix, Inc. with the FDA for Sensocor(tm) Diasys.
| Device ID | K881771 |
| 510k Number | K881771 |
| Device Name: | SENSOCOR(TM) DIASYS |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SENSORMEDIX, INC. 1001 W. CYPRESS CREEK RD. #300M Fort Lauderdale, FL 33309 |
| Contact | Robert P Silver |
| Correspondent | Robert P Silver SENSORMEDIX, INC. 1001 W. CYPRESS CREEK RD. #300M Fort Lauderdale, FL 33309 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-26 |
| Decision Date | 1989-01-12 |