FDA 510(k)

Profoject™ Safety Sliding Blood Collection Set

K-번호: K262215 · 2026-09-25

결정일2026-09-25

제품 코드JKA

자문 위원회CH

결정Substantially Equivalent

기기 요약

Profoject™ Safety Sliding Blood Collection Set is the device name listed in this FDA 510(k) record. The listed applicant is CMT Health PTE., Ltd.. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K262215. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Profoject™ Safety Sliding Blood Collection Set?

Profoject™ Safety Sliding Blood Collection Set is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is CMT Health PTE., Ltd.. The 510(k) number is K262215.

When did Profoject™ Safety Sliding Blood Collection Set receive FDA 510(k) clearance?

Profoject™ Safety Sliding Blood Collection Set received FDA 510(k) clearance on 2026-09-25, under 510(k) number K262215.

Who is the listed applicant for Profoject™ Safety Sliding Blood Collection Set?

The FDA 510(k) record lists CMT Health PTE., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Profoject™ Safety Sliding Blood Collection Set?

The FDA product code for Profoject™ Safety Sliding Blood Collection Set is JKA.

CMT Health PTE., Ltd.를 신청인으로 등재한 기타 기록

K261372Profoject™ LOR Syringe K261829Profoject™ Dual-Safety Pen Needles K260739Profoject™ Pen Needles (Model A; Model B)K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle K260855Profoject™ Safety Pen Needles K253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap

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