BMC Medical Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Portable Oxygen Concentrator (PO1 5B, PO1 6B), F6S Full Face Mask (F6S), Respiration Data Management Software (PAP Link PC)
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - BMC Medical Co., Ltd. Anesthesiology ✕
6 devices
Cleared
Aug 14, 2026
Portable Oxygen Concentrator (PO1 5B, PO1 6B)
Anesthesiology
205d
Cleared
Apr 29, 2026
F6S Full Face Mask (F6S)
Anesthesiology
215d
Cleared
Jan 15, 2025
Respiration Data Management Software (PAP Link PC)
Anesthesiology
112d
Cleared
Dec 05, 2022
BPAP System
Anesthesiology
433d
Cleared
Mar 09, 2022
Auto CPAP System
Anesthesiology
324d
Cleared
Apr 23, 2014
NASAL MASK, NASAL MASK, FULL FACE MASK
Anesthesiology
210d