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FDA 510(k)

CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY

K-Number: K122196 · 2013-05-02

ApplicantBlackrock Neuromed, LLC
Decision Date2013-05-02
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY is the device name listed in this FDA 510(k) record. The listed applicant is Blackrock Neuromed, LLC. It received FDA 510(k) clearance on 2013-05-02 under 510(k) number K122196. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY?

CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY is a medical device that received FDA 510(k) clearance on 2013-05-02. The listed applicant is Blackrock Neuromed, LLC. The 510(k) number is K122196.

When did CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY receive FDA 510(k) clearance?

CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY received FDA 510(k) clearance on 2013-05-02, under 510(k) number K122196.

Who is the listed applicant for CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY?

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

What is the FDA product code for CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY?

The FDA product code for CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY is GWQ.

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Related Devices (Code: GWQ)

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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