Ultrasonic Doppler (Model YM-2T8)— 510(k) K180419

Name: FDA 510(k) clearance K180419
Creator: U.S. Food and Drug Administration
Published: 2018-07-19

Substantially Equivalent

Shenzhen Imdk Medical Technology Co., Ltd.

FDA 510(k) clearance K180419 for Ultrasonic Doppler (Model YM-2T8), Substantially Equivalent on 2018-07-19. Applicant: Shenzhen Imdk Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Imdk Medical Technology Co., Ltd.
Product code: Code KNG
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 2018-02-15
Decision date: 2018-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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