NinesAI
K-Number: K193351 · 2020-04-21
ApplicantNines, Inc.
Decision Date2020-04-21
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
NinesAI is a medical device manufactured by Nines, Inc.. It received FDA 510(k) clearance on 2020-04-21 under approval number K193351. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NinesAI?
NinesAI is a medical device that received FDA 510(k) clearance on 2020-04-21. It is manufactured by Nines, Inc.. The 510(k) number is K193351.
When was NinesAI approved by the FDA?
NinesAI received FDA 510(k) clearance on 2020-04-21, under approval number K193351.
What company makes NinesAI?
NinesAI is manufactured by Nines, Inc..
What is the FDA product code for NinesAI?
The FDA product code for NinesAI is QAS.
Other Devices by Nines, Inc.
Related Devices (Code: QAS)
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.