The following data is part of a premarket notification filed by H4d Sas with the FDA for Consult Station Ts.
| Device ID | K153600 |
| 510k Number | K153600 |
| Device Name: | Consult Station TS |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | H4D SAS 92 AVENUE KLEBER Paris, FR |
| Contact | Marta Rivas |
| Correspondent | Esin Yesilalan VOISIN CONSULTING LIFE SCIENCES 222 THIRD STREET SUITE 3121 Cambridge, MA 02142 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-16 |
| Decision Date | 2017-03-17 |
| Summary: | summary |