FDA 510(k)

SOL-GUARD Safety Pull Button Collection Set

K-번호: K213718 · 2022-08-30

결정일2022-08-30

제품 코드JKA

자문 위원회CH [기업명]의 [제품명]은 미국 식품의약국(FDA)에서 510(k) 등록을 완료한 의료기기입니다. 이 제품은 [PMA] 및 [NCT] 등록을 완료하였으며, [PMID]로 확인할 수 있습니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL].

결정Substantially Equivalent

기기 요약

SOL-GUARD Safety Pull Button Collection Set is the device name listed in this FDA 510(k) record. The listed applicant is Sol-Millennium Medical, Inc.. It received FDA 510(k) clearance on 2022-08-30 under 510(k) number K213718. 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 SOL-GUARD Safety Pull Button Collection Set?

SOL-GUARD Safety Pull Button Collection Set is a medical device that received FDA 510(k) clearance on 2022-08-30. The listed applicant is Sol-Millennium Medical, Inc.. The 510(k) number is K213718.

When did SOL-GUARD Safety Pull Button Collection Set receive FDA 510(k) clearance?

SOL-GUARD Safety Pull Button Collection Set received FDA 510(k) clearance on 2022-08-30, under 510(k) number K213718.

Who is the listed applicant for SOL-GUARD Safety Pull Button Collection Set?

The FDA 510(k) record lists Sol-Millennium Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOL-GUARD Safety Pull Button Collection Set?

The FDA product code for SOL-GUARD Safety Pull Button Collection Set is JKA.

Sol-Millennium Medical, Inc.를 신청인으로 등재한 기타 기록

K252184SOL-M Luer Lock Syringe with Exchangeable Needle Tray K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe K250907Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set K242291SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle K242099Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle K241821루어 락 주사기 및 안전 주사针; 루어 락 주사기 및 교환 가능 주사针; 루어 락 주사기 및 무늬 주사针

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