Cleared Traditional

ECHOFLOW DOPPLER BLOOD VELOCITY METER

K990642 · Echocath, Inc. · Cardiovascular
Sep 1999
Decision
202d
Days
Class 2
Risk

About This 510(k) Submission

K990642 is an FDA 510(k) clearance for the ECHOFLOW DOPPLER BLOOD VELOCITY METER, a Transducer, Ultrasonic (Class II — Special Controls, product code JOP), submitted by Echocath, Inc. (Monmouth Junction, US). The FDA issued a Cleared decision on September 16, 1999, 202 days after receiving the submission on February 26, 1999. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2880.

Submission Details

510(k) Number K990642 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 1999
Decision Date September 16, 1999
Days to Decision 202 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code JOP — Transducer, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2880