510(k) K263254
K263254 is an FDA 510(k) premarket notification submitted by Xiamen Compower Medical Tech. Co., Ltd. for the device "Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1)". The FDA issued a decision of Substantially Equivalent on Oct 16, 2026. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Xiamen Compower Medical Tech. Co., Ltd. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 16, 2026
- Date Received
- Sep 17, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Emergency, Manual (Resuscitator)
- Device Class
- Class II
- Regulation Number
- 868.5915
- Review Panel
- AN
- Submission Type
- 510(k)