FDA 510(k)

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

K号: K200968 · 2020-12-28

决定日期2020-12-28

产品代码CBI

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决定实质等同

器械摘要

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.

常见问题

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.

相关器械（代码：CBI）

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