FDA 510(k)

NovaLine Tubing Set for Hemodialysis (BL 124)

K-번호: K252423 · 2026-05-15

신청자Bain Medical Equipment (Guangzhou) Co., Ltd.

결정일2026-05-15

제품 코드FJK

자문 위원회GU

결정Substantially Equivalent

기기 요약

NovaLine Tubing Set for Hemodialysis (BL 124) is the device name listed in this FDA 510(k) record. The listed applicant is Bain Medical Equipment (Guangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2026-05-15 under 510(k) number K252423. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the NovaLine Tubing Set for Hemodialysis (BL 124)?

NovaLine Tubing Set for Hemodialysis (BL 124) is a medical device that received FDA 510(k) clearance on 2026-05-15. The listed applicant is Bain Medical Equipment (Guangzhou) Co., Ltd.. The 510(k) number is K252423.

When did NovaLine Tubing Set for Hemodialysis (BL 124) receive FDA 510(k) clearance?

NovaLine Tubing Set for Hemodialysis (BL 124) received FDA 510(k) clearance on 2026-05-15, under 510(k) number K252423.

Who is the listed applicant for NovaLine Tubing Set for Hemodialysis (BL 124)?

The FDA 510(k) record lists Bain Medical Equipment (Guangzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NovaLine Tubing Set for Hemodialysis (BL 124)?

The FDA product code for NovaLine Tubing Set for Hemodialysis (BL 124) is FJK.

Bain Medical Equipment (Guangzhou) Co., Ltd.를 신청인으로 등재한 기타 기록

K240164NovaLine SP-C35 Transducer Protector (956007)K213015DORA Disposable A.V. Fistula Needle Sets K201866NovaLine Tubing Sets for Hemodialysis K203524Surgical Masks K163025DORA Disposable A.V. Fistula Needle Sets K161582DORA Tubing Sets for Hemodialysis

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