ULTRASONIC POCKET DOPPLER— 510(k) K140579

Name: FDA 510(k) clearance K140579
Creator: U.S. Food and Drug Administration
Published: 2015-02-06

Substantially Equivalent

Edan Instruments, Inc.

FDA 510(k) clearance K140579 for ULTRASONIC POCKET DOPPLER, Substantially Equivalent on 2015-02-06. 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: 2014-03-06
Decision date: 2015-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, Guangdong, CN

Download summary PDF View on FDA.gov ↗

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