Cleared Traditional

K940223 - LEARN MODE WATERPROOF PENDANT PANIC BUTTON
(FDA 510(k) Clearance)

K940223 · Interactive Technologies, Inc. · Physical Medicine device

Apr 1994

Decision

101d

Days

Class 2

Risk

K940223 is an FDA 510(k) clearance for the LEARN MODE WATERPROOF PENDANT PANIC BUTTON. This device is classified as a System, Environmental Control, Powered (Class II - Special Controls, product code IQA).

Submitted by Interactive Technologies, Inc. (Washington, US). The FDA issued a Cleared decision on April 29, 1994, 101 days after receiving the submission on January 18, 1994.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3725.

Submission Details

510(k) Number	K940223 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 18, 1994
Decision Date	April 29, 1994
Days to Decision	101 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement