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 |