FDA 510(k)

펜택스 메디칼 비디오 프로세서 (EPK-i8020c)

K-번호: K251127 · 2025-06-03

결정일2025-06-03

제품 코드PEA

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

PENTAX Medical Video Processor (EPK-i8020c) is the device name listed in this FDA 510(k) record. The listed applicant is Pentax of America, Inc.. It received FDA 510(k) clearance on 2025-06-03 under 510(k) number K251127. The device is classified under product code PEA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the PENTAX Medical Video Processor (EPK-i8020c)?

PENTAX Medical Video Processor (EPK-i8020c) is a medical device that received FDA 510(k) clearance on 2025-06-03. The listed applicant is Pentax of America, Inc.. The 510(k) number is K251127.

When did PENTAX Medical Video Processor (EPK-i8020c) receive FDA 510(k) clearance?

PENTAX Medical Video Processor (EPK-i8020c) received FDA 510(k) clearance on 2025-06-03, under 510(k) number K251127.

Who is the listed applicant for PENTAX Medical Video Processor (EPK-i8020c)?

The FDA 510(k) record lists Pentax of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PENTAX Medical Video Processor (EPK-i8020c)?

The FDA product code for PENTAX Medical Video Processor (EPK-i8020c) is PEA.

Pentax of America, Inc.를 신청인으로 등재한 기타 기록

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