FDA 510(k)

Insignis 피하 주사針 세트

K-번호: K202279 · 2021-08-13

결정일2021-08-13

제품 코드FPA

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

결정대체적으로 동일

기기 요약

Insignis Subcutaneous Needle Sets is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health Sciences, LLC. It received FDA 510(k) clearance on 2021-08-13 under 510(k) number K202279. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Insignis Subcutaneous Needle Sets?

Insignis Subcutaneous Needle Sets is a medical device that received FDA 510(k) clearance on 2021-08-13. The listed applicant is Innovative Health Sciences, LLC. The 510(k) number is K202279.

When did Insignis Subcutaneous Needle Sets receive FDA 510(k) clearance?

Insignis Subcutaneous Needle Sets received FDA 510(k) clearance on 2021-08-13, under 510(k) number K202279.

Who is the listed applicant for Insignis Subcutaneous Needle Sets?

The FDA 510(k) record lists Innovative Health Sciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Insignis Subcutaneous Needle Sets?

The FDA product code for Insignis Subcutaneous Needle Sets is FPA.

Innovative Health Sciences, LLC를 신청인으로 등재한 기타 기록

K232328Insignis™ 주사 투여 시스템

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