510(k) K901029

YES-NO VOICE BOX 7011 by Baylor Biomedical Services — Product Code ILQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1990
Date Received
March 6, 1990
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