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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Innovative Neurological Devices, LLC. It received FDA 510(k) clearance on 2019-03-07 under 510(k) 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. The listed applicant is Innovative Neurological Devices, LLC. The 510(k) number is K182311.

When did Cervella receive FDA 510(k) clearance?

Cervella received FDA 510(k) clearance on 2019-03-07, under 510(k) number K182311.

Who is the listed applicant for Cervella?

The FDA 510(k) record lists Innovative Neurological Devices, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cervella?

The FDA product code for Cervella is QJQ.

Related Devices (Code: QJQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252951Genesis SleepNeurofield, Inc.K232253Modius StressNeurovalens LimitedK230826Modius SleepNeurovalens , Ltd.

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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