510(k) clearance

Profoject™ LOR Syringe

FDA 510(k) source

510(k) number

K261372

Applicant

CMT Health PTE., Ltd.

Decision date

Sep 25, 2026

Date received

Apr 27, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

CAZ

Device type

Anesthesia Conduction Kit

Device class

Class II

Regulation

21 CFR 868.5140

Advisory committee

Anesthesiology

Statement or summary

Summary

Third party

N

Location

Singapore, SG