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FDA 510(k)

4312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH

K-Number: K854665 · 1986-06-05

ApplicantNihon Kohden America, Inc.
Decision Date1986-06-05
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

4312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH 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 1986-06-05 under 510(k) number K854665. 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 4312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH?

4312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH is a medical device that received FDA 510(k) clearance on 1986-06-05. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K854665.

When did 4312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH receive FDA 510(k) clearance?

4312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH received FDA 510(k) clearance on 1986-06-05, under 510(k) number K854665.

Who is the listed applicant for 4312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH?

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 4312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH?

The FDA product code for 4312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH is OLV.

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Other records listing Nihon Kohden America, Inc. as applicant

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Related Devices (Code: 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.

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