FDA 510(k)

PSG INPUT BOX, MODEL JE-912AK

K-Number: K022121 · 2002-07-29

Decision Date2002-07-29

Product CodeOLV

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

PSG INPUT BOX, MODEL JE-912AK 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 2002-07-29 under 510(k) number K022121. 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 PSG INPUT BOX, MODEL JE-912AK?

PSG INPUT BOX, MODEL JE-912AK is a medical device that received FDA 510(k) clearance on 2002-07-29. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K022121.

When did PSG INPUT BOX, MODEL JE-912AK receive FDA 510(k) clearance?

PSG INPUT BOX, MODEL JE-912AK received FDA 510(k) clearance on 2002-07-29, under 510(k) number K022121.

Who is the listed applicant for PSG INPUT BOX, MODEL JE-912AK?

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 PSG INPUT BOX, MODEL JE-912AK?

The FDA product code for PSG INPUT BOX, MODEL JE-912AK is OLV.

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Official Source

View on FDA Database →

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