ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R
K-Number: K200968 · 2020-12-28
ApplicantInsung Medical Co., Ltd.
Decision Date2020-12-28
Product CodeCBI
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R is a medical device manufactured by Insung Medical Co., Ltd.. It received FDA 510(k) clearance on 2020-12-28 under approval number K200968. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
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. It is manufactured by Insung Medical Co., Ltd.. The 510(k) number is K200968.
When was ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R approved by the FDA?
ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R received FDA 510(k) clearance on 2020-12-28, under approval number K200968.
What company makes ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R?
ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R is manufactured by Insung Medical Co., Ltd..
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.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.