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FDA 510(k)

NEURON MAX SYSTEM

K-Number: K111380 · 2011-07-19

ApplicantPenumbra, Inc.
Decision Date2011-07-19
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEURON MAX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2011-07-19 under 510(k) number K111380. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEURON MAX SYSTEM?

NEURON MAX SYSTEM is a medical device that received FDA 510(k) clearance on 2011-07-19. The listed applicant is Penumbra, Inc.. The 510(k) number is K111380.

When did NEURON MAX SYSTEM receive FDA 510(k) clearance?

NEURON MAX SYSTEM received FDA 510(k) clearance on 2011-07-19, under 510(k) number K111380.

Who is the listed applicant for NEURON MAX SYSTEM?

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

What is the FDA product code for NEURON MAX SYSTEM?

The FDA product code for NEURON MAX SYSTEM is DQY.

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Other records listing Penumbra, Inc. as applicant

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Related Devices (Code: DQY)

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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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