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FDA 510(k)

BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM

K-Number: K090957 · 2009-05-28

ApplicantI2s Micro Implantable Systems, LLC
Decision Date2009-05-28
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is I2s Micro Implantable Systems, LLC. It received FDA 510(k) clearance on 2009-05-28 under 510(k) number K090957. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM?

BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM is a medical device that received FDA 510(k) clearance on 2009-05-28. The listed applicant is I2s Micro Implantable Systems, LLC. The 510(k) number is K090957.

When did BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM receive FDA 510(k) clearance?

BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM received FDA 510(k) clearance on 2009-05-28, under 510(k) number K090957.

Who is the listed applicant for BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM?

The FDA 510(k) record lists I2s Micro Implantable Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM?

The FDA product code for BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM is GWL.

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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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