Cleared Traditional

K930044 - COMFORT KEYBOARD SYSTEM
(FDA 510(k) Clearance)

K930044 · Health Care Keyboard Co., Inc. · Physical Medicine device

Jul 1994

Decision

555d

Days

Class 2

Risk

K930044 is an FDA 510(k) clearance for the COMFORT KEYBOARD SYSTEM. This device is classified as a System, Communication, Powered (Class II - Special Controls, product code ILQ).

Submitted by Health Care Keyboard Co., Inc. (Menomonee Falls, US). The FDA issued a Cleared decision on July 14, 1994, 555 days after receiving the submission on January 5, 1993.

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

Submission Details

510(k) Number	K930044 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 05, 1993
Decision Date	July 14, 1994
Days to Decision	555 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF