510(k) clearance

PolySense

FDA 510(k) source

510(k) number

K260648

Applicant

Itamar Medical , Ltd.

Decision date

Oct 30, 2026

Date received

Feb 27, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

GWL

Device type

Amplifier, Physiological Signal

Device class

Class II

Regulation

21 CFR 882.1835

Advisory committee

Neurology

Statement or summary

Summary

Third party

N

Location

Caesarea, IL