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FDA 510(k)

NEUROPACK 8, MEE-4108

K-Number: K851300 · 1985-06-13

ApplicantNihon Kohden America, Inc.
Decision Date1985-06-13
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROPACK 8, MEE-4108 is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden America, Inc.. It received FDA 510(k) clearance on 1985-06-13 under 510(k) number K851300. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROPACK 8, MEE-4108?

NEUROPACK 8, MEE-4108 is a medical device that received FDA 510(k) clearance on 1985-06-13. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K851300.

When did NEUROPACK 8, MEE-4108 receive FDA 510(k) clearance?

NEUROPACK 8, MEE-4108 received FDA 510(k) clearance on 1985-06-13, under 510(k) number K851300.

Who is the listed applicant for NEUROPACK 8, MEE-4108?

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

What is the FDA product code for NEUROPACK 8, MEE-4108?

The FDA product code for NEUROPACK 8, MEE-4108 is GWF.

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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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