The following data is part of a premarket notification filed by Iowa Adaptive Technologies, Inc. Dba Voxello, Inc. with the FDA for Noddle(tm).
| Device ID | K162817 |
| 510k Number | K162817 |
| Device Name: | Noddle(TM) |
| Classification | System, Communication, Powered |
| Applicant | IOWA ADAPTIVE TECHNOLOGIES, INC. DBA VOXELLO, INC. 2500 CROSSPARK ROAD STE W150 Coralville, IA 52241 |
| Contact | R. Rives Bird |
| Correspondent | R. Rives Bird IOWA ADAPTIVE TECHNOLOGIES, INC. DBA VOXELLO, INC. 2500 CROSSPARK ROAD STE W150 Coralville, IA 52241 |
| Product Code | ILQ |
| CFR Regulation Number | 890.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-06 |
| Decision Date | 2017-01-18 |
| Summary: | summary |