FDA 510(k)

マイクロリ터ドosing注射器（9、20、25、37.5、50および100マイクロリターモデル）

K-번호: K243149 · 2024-12-20

결정일2024-12-20

제품 코드QLY

자문 위원회의료장비 규제 텍스트 번역 HO [원문 텍스트가 제공되지 않았기 때문에 번역할 수 없습니다. 원문 텍스트를 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) is the device name listed in this FDA 510(k) record. The listed applicant is Congruence Medical Solutions, LLC. It received FDA 510(k) clearance on 2024-12-20 under 510(k) number K243149. The device is classified under product code QLY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)?

Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Congruence Medical Solutions, LLC. The 510(k) number is K243149.

When did Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) receive FDA 510(k) clearance?

Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) received FDA 510(k) clearance on 2024-12-20, under 510(k) number K243149.

Who is the listed applicant for Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)?

The FDA 510(k) record lists Congruence Medical Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)?

The FDA product code for Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) is QLY.

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FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

マイクロリ터ドosing注射器（9、20、25、37.5、50および100マイクロリターモデル）

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: QLY)

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