Cleared Special

ECHOSCAN, MODEL US-1800

K020876 · Nidek, Inc. · Radiology
May 2002
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K020876 is an FDA 510(k) clearance for the ECHOSCAN, MODEL US-1800, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Nidek, Inc. (Lake Forest, US). The FDA issued a Cleared decision on May 3, 2002, 46 days after receiving the submission on March 18, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K020876 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2002
Decision Date May 03, 2002
Days to Decision 46 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYO — System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1560

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