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FDA 510(k)

Cervello STIM

K-Number: K151354 · 2016-01-27

ApplicantBlackrock Neuromed
Decision Date2016-01-27
Product CodeGYC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Cervello STIM is the device name listed in this FDA 510(k) record. The listed applicant is Blackrock Neuromed. It received FDA 510(k) clearance on 2016-01-27 under 510(k) number K151354. The device is classified under product code GYC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cervello STIM?

Cervello STIM is a medical device that received FDA 510(k) clearance on 2016-01-27. The listed applicant is Blackrock Neuromed. The 510(k) number is K151354.

When did Cervello STIM receive FDA 510(k) clearance?

Cervello STIM received FDA 510(k) clearance on 2016-01-27, under 510(k) number K151354.

Who is the listed applicant for Cervello STIM?

The FDA 510(k) record lists Blackrock Neuromed as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cervello STIM?

The FDA product code for Cervello STIM is GYC.

Related Devices (Code: GYC)

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.

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Official Source

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

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