FDA 510(k)

인수펜 펜 nål, 인수펜 ORIGINAl 펜 nål, 인수펜 ADVANCED 펜 nål

K-번호: K203792 · 2023-01-20

결정일2023-01-20

제품 코드FMI

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

결정대체적으로 동일

기기 요약

Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle is the device name listed in this FDA 510(k) record. The listed applicant is Pikdare Spa. It received FDA 510(k) clearance on 2023-01-20 under 510(k) number K203792. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle?

Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle is a medical device that received FDA 510(k) clearance on 2023-01-20. The listed applicant is Pikdare Spa. The 510(k) number is K203792.

When did Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle receive FDA 510(k) clearance?

Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle received FDA 510(k) clearance on 2023-01-20, under 510(k) number K203792.

Who is the listed applicant for Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle?

The FDA 510(k) record lists Pikdare Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle?

The FDA product code for Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle is FMI.

Pikdare Spa를 신청인으로 등재한 기타 기록

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