FDA 510(k)

NEUROFAX, MODEL EEG-1100A

K-Number: K992742 · 1999-10-14

Decision Date1999-10-14

Product CodeOLV

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

NEUROFAX, MODEL EEG-1100A 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 1999-10-14 under 510(k) number K992742. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROFAX, MODEL EEG-1100A?

NEUROFAX, MODEL EEG-1100A is a medical device that received FDA 510(k) clearance on 1999-10-14. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K992742.

When did NEUROFAX, MODEL EEG-1100A receive FDA 510(k) clearance?

NEUROFAX, MODEL EEG-1100A received FDA 510(k) clearance on 1999-10-14, under 510(k) number K992742.

Who is the listed applicant for NEUROFAX, MODEL EEG-1100A?

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 NEUROFAX, MODEL EEG-1100A?

The FDA product code for NEUROFAX, MODEL EEG-1100A is OLV.

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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.