510(k) K162817

Noddle(TM) by Iowa Adaptive Technologies, Inc. Dba Voxello, Inc. — Product Code ILQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2017
Date Received
October 6, 2016
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