FDA 510(k)

Double Balloon Endoscope EN-840T, Over-tube TS-1214C

K号: K233321 · 2024-06-13

申请人FUJIFILM Healthcare Americas Corporation

决定日期2024-06-13

产品代码FDA

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决定实质等同

器械摘要

Double Balloon Endoscope EN-840T, Over-tube TS-1214C is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2024-06-13 under 510(k) number K233321. The device is classified under product code FDA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Double Balloon Endoscope EN-840T, Over-tube TS-1214C?

Double Balloon Endoscope EN-840T, Over-tube TS-1214C is a medical device that received FDA 510(k) clearance on 2024-06-13. The listed applicant is FUJIFILM Healthcare Americas Corporation. The 510(k) number is K233321.

When did Double Balloon Endoscope EN-840T, Over-tube TS-1214C receive FDA 510(k) clearance?

Double Balloon Endoscope EN-840T, Over-tube TS-1214C received FDA 510(k) clearance on 2024-06-13, under 510(k) number K233321.

Who is the listed applicant for Double Balloon Endoscope EN-840T, Over-tube TS-1214C?

The FDA 510(k) record lists FUJIFILM Healthcare Americas Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Double Balloon Endoscope EN-840T, Over-tube TS-1214C?

The FDA product code for Double Balloon Endoscope EN-840T, Over-tube TS-1214C is FDA.

列明FUJIFILM Healthcare Americas Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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