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FDA 510(k)

NEUROPACK MICRO, MODEL MED-9100A SERIES

K-Number: K010590 · 2001-06-28

ApplicantNihon Kohden America, Inc.
Decision Date2001-06-28
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

NEUROPACK MICRO, MODEL MED-9100A SERIES 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 2001-06-28 under 510(k) number K010590. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROPACK MICRO, MODEL MED-9100A SERIES?

NEUROPACK MICRO, MODEL MED-9100A SERIES is a medical device that received FDA 510(k) clearance on 2001-06-28. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K010590.

When did NEUROPACK MICRO, MODEL MED-9100A SERIES receive FDA 510(k) clearance?

NEUROPACK MICRO, MODEL MED-9100A SERIES received FDA 510(k) clearance on 2001-06-28, under 510(k) number K010590.

Who is the listed applicant for NEUROPACK MICRO, MODEL MED-9100A SERIES?

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 MICRO, MODEL MED-9100A SERIES?

The FDA product code for NEUROPACK MICRO, MODEL MED-9100A SERIES is IKN.

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Other records listing Nihon Kohden America, Inc. 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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Related Devices (Code: IKN)

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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