The following data is part of a premarket notification filed by Health Care Keyboard Co., Inc. with the FDA for Comfort Keyboard System.
Device ID | K930044 |
510k Number | K930044 |
Device Name: | COMFORT KEYBOARD SYSTEM |
Classification | System, Communication, Powered |
Applicant | HEALTH CARE KEYBOARD CO., INC. N82 W15340 APPLETON AVE. Menomonee Falls, WI 53051 |
Contact | Jeffrey Szmanda |
Correspondent | Jeffrey Szmanda HEALTH CARE KEYBOARD CO., INC. N82 W15340 APPLETON AVE. Menomonee Falls, WI 53051 |
Product Code | ILQ |
CFR Regulation Number | 890.3710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-05 |
Decision Date | 1994-07-14 |
Summary: | summary |