510(k) clearance

BiWaze Clear System

FDA 510(k) source

510(k) number

K260604

Applicant

Abmrc, LLC

Decision date

Aug 24, 2026

Date received

Feb 24, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

NHJ

Device type

Device, Positive Pressure Breathing, Intermittent

Device class

Class II

Regulation

21 CFR 868.5905

Advisory committee

Anesthesiology

Statement or summary

Summary

Third party

N

Location

Eagan, MN, US