Cleared Traditional

NUWAV

K081781 · Laborie Medical Technologies, Corp. · Radiology
Jul 2008
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K081781 is an FDA 510(k) clearance for the NUWAV, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Laborie Medical Technologies, Corp. (Williston, US). The FDA issued a Cleared decision on July 9, 2008, 15 days after receiving the submission on June 24, 2008. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K081781 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 2008
Decision Date July 09, 2008
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

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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