ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6— 510(k) K092997

Substantially Equivalent

Edan Instruments, Inc.

FDA 510(k) clearance K092997 for ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6, Substantially Equivalent on 2009-11-10. Applicant: Edan Instruments, Inc..

Clearance details

Applicant: Edan Instruments, Inc.
Product code: Code KNG
Advisory panel: Obstetrics/Gynecology
Date received: 2009-09-28
Decision date: 2009-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yonkers, NY, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.