Cleared Traditional

ECLIPSE PROBE COVER

K953673 · Parker Laboratories, Inc. · Radiology
Mar 1996
Decision
220d
Days
Class 2
Risk

About This 510(k) Submission

K953673 is an FDA 510(k) clearance for the ECLIPSE PROBE COVER, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Parker Laboratories, Inc. (Orange, US). The FDA issued a Cleared decision on March 14, 1996, 220 days after receiving the submission on August 7, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K953673 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 1995
Decision Date March 14, 1996
Days to Decision 220 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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