510(k) clearance

Digistat Care

FDA 510(k) source

510(k) number

K261287

Applicant

Ascom Ums Srl Unipersonale

Decision date

Sep 12, 2026

Date received

Apr 20, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

MSX

Device type

System, Network And Communication, Physiological Monitors

Device class

Class II

Regulation

21 CFR 870.2300

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

Scandicci (Fi), IT