Cleared Special

SONOTRAX SERIES ULTRASONIC POCKET DOPPLER

K101960 · Edan Instruments, Inc. · Radiology
Aug 2010
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K101960 is an FDA 510(k) clearance for the SONOTRAX SERIES ULTRASONIC POCKET DOPPLER, a Monitor, Blood-flow, Ultrasonic (Class II — Special Controls, product code HEP), submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on August 10, 2010, 29 days after receiving the submission on July 12, 2010. This device falls under the Radiology review panel. Regulated under 21 CFR 884.2660.

Submission Details

510(k) Number K101960 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 2010
Decision Date August 10, 2010
Days to Decision 29 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code HEP — Monitor, Blood-flow, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.2660

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