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FDA 510(k)

WEP 7604 TELEMETRY MONITOR

K-Number: K854369 · 1986-02-28

ApplicantNihon Kohden America, Inc.
Decision Date1986-02-28
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WEP 7604 TELEMETRY MONITOR 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 1986-02-28 under 510(k) number K854369. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WEP 7604 TELEMETRY MONITOR?

WEP 7604 TELEMETRY MONITOR is a medical device that received FDA 510(k) clearance on 1986-02-28. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K854369.

When did WEP 7604 TELEMETRY MONITOR receive FDA 510(k) clearance?

WEP 7604 TELEMETRY MONITOR received FDA 510(k) clearance on 1986-02-28, under 510(k) number K854369.

Who is the listed applicant for WEP 7604 TELEMETRY MONITOR?

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 WEP 7604 TELEMETRY MONITOR?

The FDA product code for WEP 7604 TELEMETRY MONITOR is DXH. This falls under the Hematology category.

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Other records listing Nihon Kohden America, Inc. as applicant

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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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