510(k) clearance

Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1)

FDA 510(k) source

510(k) number

K263254

Applicant

Xiamen Compower Medical Tech. Co., Ltd.

Decision date

Oct 16, 2026

Date received

Sep 17, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

BTM

Device type

Ventilator, Emergency, Manual (Resuscitator)

Device class

Class II

Regulation

21 CFR 868.5915

Advisory committee

Anesthesiology

Statement or summary

Statement

Third party

N

Location

Xiamen, CN