510(k) K930044

COMFORT KEYBOARD SYSTEM by Health Care Keyboard Co., Inc. — Product Code ILQ

K930044 is an FDA 510(k) premarket notification submitted by Health Care Keyboard Co., Inc. for the device "COMFORT KEYBOARD SYSTEM". The FDA issued a decision of Substantially Equivalent on July 14, 1994. The device falls under product code ILQ (System, Communication, Powered), a Class II device regulated under 21 CFR 890.3710.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1994
Date Received
January 5, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Communication, Powered
Device Class
Class II
Regulation Number
890.3710
Review Panel
PM
Submission Type