SD5 & SD6 Ultrasonic Tabletop Doppler— 510(k) K153475

Name: FDA 510(k) clearance K153475
Creator: U.S. Food and Drug Administration
Published: 2016-01-29

Substantially Equivalent

Edan Instruments, Inc.

FDA 510(k) clearance K153475 for SD5 & SD6 Ultrasonic Tabletop Doppler, Substantially Equivalent on 2016-01-29. Applicant: Edan Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Edan Instruments, Inc.
Product code: Code KNG
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 2015-12-02
Decision date: 2016-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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