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FDA 510(k)

ORG-8200A UNIVERSAL SIGNAL HOUSING

K-Number: K912744 · 1991-12-09

ApplicantNihon Kohden America, Inc.
Decision Date1991-12-09
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ORG-8200A UNIVERSAL SIGNAL HOUSING 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 1991-12-09 under 510(k) number K912744. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORG-8200A UNIVERSAL SIGNAL HOUSING?

ORG-8200A UNIVERSAL SIGNAL HOUSING is a medical device that received FDA 510(k) clearance on 1991-12-09. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K912744.

When did ORG-8200A UNIVERSAL SIGNAL HOUSING receive FDA 510(k) clearance?

ORG-8200A UNIVERSAL SIGNAL HOUSING received FDA 510(k) clearance on 1991-12-09, under 510(k) number K912744.

Who is the listed applicant for ORG-8200A UNIVERSAL SIGNAL HOUSING?

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 ORG-8200A UNIVERSAL SIGNAL HOUSING?

The FDA product code for ORG-8200A UNIVERSAL SIGNAL HOUSING is DSI.

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Other records listing Nihon Kohden America, Inc. as applicant

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Related Devices (Code: DSI)

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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