FDA 510(k)

TDS 표준 솔루션

K-번호: K191496 · 2019-08-05

결정일2019-08-05

제품 코드FKH

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

TDS Standard Solution is the device name listed in this FDA 510(k) record. The listed applicant is Mesa Laboratories, Inc.. It received FDA 510(k) clearance on 2019-08-05 under 510(k) number K191496. The device is classified under product code FKH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the TDS Standard Solution?

TDS Standard Solution is a medical device that received FDA 510(k) clearance on 2019-08-05. The listed applicant is Mesa Laboratories, Inc.. The 510(k) number is K191496.

When did TDS Standard Solution receive FDA 510(k) clearance?

TDS Standard Solution received FDA 510(k) clearance on 2019-08-05, under 510(k) number K191496.

Who is the listed applicant for TDS Standard Solution?

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

What is the FDA product code for TDS Standard Solution?

The FDA product code for TDS Standard Solution is FKH.

Mesa Laboratories, Inc.를 신청인으로 등재한 기타 기록

K201765스마트HDM-510 시스템

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기기 요약

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관련 임상시험

Mesa Laboratories, Inc.를 신청인으로 등재한 기타 기록

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