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FDA 510(k)

ELECTRODE JUNCTION BOX, MODEL JE-921A

K-Number: K050833 · 2005-04-29

ApplicantNihon Kohden America, Inc.
Decision Date2005-04-29
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELECTRODE JUNCTION BOX, MODEL JE-921A 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 2005-04-29 under 510(k) number K050833. 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 ELECTRODE JUNCTION BOX, MODEL JE-921A?

ELECTRODE JUNCTION BOX, MODEL JE-921A is a medical device that received FDA 510(k) clearance on 2005-04-29. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K050833.

When did ELECTRODE JUNCTION BOX, MODEL JE-921A receive FDA 510(k) clearance?

ELECTRODE JUNCTION BOX, MODEL JE-921A received FDA 510(k) clearance on 2005-04-29, under 510(k) number K050833.

Who is the listed applicant for ELECTRODE JUNCTION BOX, MODEL JE-921A?

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 ELECTRODE JUNCTION BOX, MODEL JE-921A?

The FDA product code for ELECTRODE JUNCTION BOX, MODEL JE-921A 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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