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FDA 510(k)

Noddle(TM)

K-Number: K162817 · 2017-01-18

ApplicantIowa Adaptive Technologies, Inc. Dba Voxello, Inc.
Decision Date2017-01-18
Product CodeILQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Noddle(TM) is a medical device manufactured by Iowa Adaptive Technologies, Inc. Dba Voxello, Inc.. It received FDA 510(k) clearance on 2017-01-18 under approval number K162817. The device is classified under product code ILQ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Noddle(TM)?

Noddle(TM) is a medical device that received FDA 510(k) clearance on 2017-01-18. It is manufactured by Iowa Adaptive Technologies, Inc. Dba Voxello, Inc.. The 510(k) number is K162817.

When was Noddle(TM) approved by the FDA?

Noddle(TM) received FDA 510(k) clearance on 2017-01-18, under approval number K162817.

What company makes Noddle(TM)?

Noddle(TM) is manufactured by Iowa Adaptive Technologies, Inc. Dba Voxello, Inc..

What is the FDA product code for Noddle(TM)?

The FDA product code for Noddle(TM) is ILQ.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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