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FDA 510(k)

ACCIN BIPOLAR HEAD SYSTEM

K-Number: K080647 · 2008-07-08

ApplicantAccelerated Innovation, LLC
Decision Date2008-07-08
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACCIN BIPOLAR HEAD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Accelerated Innovation, LLC. It received FDA 510(k) clearance on 2008-07-08 under 510(k) number K080647. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCIN BIPOLAR HEAD SYSTEM?

ACCIN BIPOLAR HEAD SYSTEM is a medical device that received FDA 510(k) clearance on 2008-07-08. The listed applicant is Accelerated Innovation, LLC. The 510(k) number is K080647.

When did ACCIN BIPOLAR HEAD SYSTEM receive FDA 510(k) clearance?

ACCIN BIPOLAR HEAD SYSTEM received FDA 510(k) clearance on 2008-07-08, under 510(k) number K080647.

Who is the listed applicant for ACCIN BIPOLAR HEAD SYSTEM?

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

What is the FDA product code for ACCIN BIPOLAR HEAD SYSTEM?

The FDA product code for ACCIN BIPOLAR HEAD SYSTEM is KWY.

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Other records listing Accelerated Innovation, LLC as applicant

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

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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