Cleared Traditional

K923819 - EEC-1 PACKAGE (FDA 510(k) Clearance)

K923819 · Med Labs, Inc. · Physical Medicine device

Nov 1992

Decision

99d

Days

Class 2

Risk

K923819 is an FDA 510(k) clearance for the EEC-1 PACKAGE. This device is classified as a System, Communication, Powered (Class II - Special Controls, product code ILQ).

Submitted by Med Labs, Inc. (Goleta, US). The FDA issued a Cleared decision on November 6, 1992, 99 days after receiving the submission on July 30, 1992.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3710.

Submission Details

510(k) Number	K923819 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 30, 1992
Decision Date	November 06, 1992
Days to Decision	99 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF