Noddle(TM)
K-Number: K162817 · 2017-01-18
Decision Date2017-01-18
Product CodeILQ
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Noddle(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Iowa Adaptive Technologies, Inc. Dba Voxello, Inc.. It received FDA 510(k) clearance on 2017-01-18 under 510(k) 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. The listed applicant is Iowa Adaptive Technologies, Inc. Dba Voxello, Inc.. The 510(k) number is K162817.
When did Noddle(TM) receive FDA 510(k) clearance?
Noddle(TM) received FDA 510(k) clearance on 2017-01-18, under 510(k) number K162817.
Who is the listed applicant for Noddle(TM)?
The FDA 510(k) record lists Iowa Adaptive Technologies, Inc. Dba Voxello, Inc. as the applicant. This does not by itself establish the device manufacturer.
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.