Cleared Special

ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1

K010482 · Echocath, Inc. · Cardiovascular

Mar 2001

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K010482 is an FDA 510(k) clearance for the ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1, a Transducer, Ultrasonic (Class II — Special Controls, product code JOP), submitted by Echocath, Inc. (Monmouth Junction, US). The FDA issued a Cleared decision on March 20, 2001, 28 days after receiving the submission on February 20, 2001. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2880.

Submission Details

510(k) Number	K010482 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 20, 2001
Decision Date	March 20, 2001
Days to Decision	28 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF