Cervella
K-Number: K182311 · 2019-03-07
ApplicantInnovative Neurological Devices, LLC
Decision Date2019-03-07
Product CodeQJQ
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Cervella is a medical device manufactured by Innovative Neurological Devices, LLC. It received FDA 510(k) clearance on 2019-03-07 under approval number K182311. The device is classified under product code QJQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cervella?
Cervella is a medical device that received FDA 510(k) clearance on 2019-03-07. It is manufactured by Innovative Neurological Devices, LLC. The 510(k) number is K182311.
When was Cervella approved by the FDA?
Cervella received FDA 510(k) clearance on 2019-03-07, under approval number K182311.
What company makes Cervella?
Cervella is manufactured by Innovative Neurological Devices, LLC.
What is the FDA product code for Cervella?
The FDA product code for Cervella is QJQ.
Related Devices (Code: QJQ)
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.