Medical Device Manufacturer · CN , Guangzhou

Bain Medical Equipment (Guangzhou) Co., Ltd.

6 submissions · 6 cleared · Since 2017
6
Total
6
Cleared
0
Denied

Bain Medical Equipment (Guangzhou) Co., Ltd. — FDA 510(k) Submissions

Bain Medical Equipment (Guangzhou) Co., Ltd. has submitted 6 FDA 510(k) premarket notifications since 2017, of which 6 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Set, Tubing, Blood, With And Without Anti-regurgitation Valve, Needle, Fistula, Protector, Transducer, Dialysis, Mask, Surgical . Use the specialty filter in the sidebar to narrow results.

6 devices
1–6 of 6
NovaLine SP-C35 Transducer Protector (956007)
K240164 · FIB Protector, Transducer,... · Gastroenterology & Urology
Jun 2024 158d
DORA Disposable A.V. Fistula Needle Sets
K213015 · FIE Needle, Fistula · Gastroenterology & Urology
Apr 2022 200d
NovaLine Tubing Sets for Hemodialysis
K201866 · FJK Set, Tubing, Blood, With... · Gastroenterology & Urology
Mar 2021 246d
Surgical Masks
K203524 · FXX Mask, Surgical · General Hospital
Feb 2021 86d
DORA Disposable A.V. Fistula Needle Sets
K163025 · FIE Needle, Fistula · Gastroenterology & Urology
Jul 2017 262d
DORA Tubing Sets for Hemodialysis
K161582 · FJK Set, Tubing, Blood, With... · Gastroenterology & Urology
Jun 2017 373d
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