Cleared Traditional

AQUASONIC 100 ULTRASOUND TRANS. GEL,

K802146 · Parker Laboratories, Inc. · Radiology
Oct 1980
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K802146 is an FDA 510(k) clearance for the AQUASONIC 100 ULTRASOUND TRANS. GEL,, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 10, 1980, 35 days after receiving the submission on September 5, 1980. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K802146 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 1980
Decision Date October 10, 1980
Days to Decision 35 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

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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