FDA 510(k)

ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R

K 號：K200968 · 2020-12-28

決定日期2020-12-28

產品代碼CBI

諮詢委員會AN

決定相當於

器材摘要

ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R is the device name listed in this FDA 510(k) record. The listed applicant is Insung Medical Co., Ltd.. It received FDA 510(k) clearance on 2020-12-28 under 510(k) number K200968. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R?

ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R is a medical device that received FDA 510(k) clearance on 2020-12-28. The listed applicant is Insung Medical Co., Ltd.. The 510(k) number is K200968.

When did ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R receive FDA 510(k) clearance?

ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R received FDA 510(k) clearance on 2020-12-28, under 510(k) number K200968.

Who is the listed applicant for ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R?

The FDA 510(k) record lists Insung Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R?

The FDA product code for ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R is CBI.

相關器械（代碼：CBI）

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