ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER— 510(k) K102138

Name: FDA 510(k) clearance K102138
Creator: U.S. Food and Drug Administration
Published: 2010-10-28

Substantially Equivalent

Edan Instruments, Inc.

FDA 510(k) clearance K102138 for ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER, Substantially Equivalent on 2010-10-28. Applicant: Edan Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Edan Instruments, Inc.
Product code: Code MAA
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 2010-07-30
Decision date: 2010-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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