FDA 510(k)

CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES

K-Number: K040395 · 2004-06-01

Decision Date2004-06-01

Product CodeMHX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES 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 2004-06-01 under 510(k) number K040395. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES?

CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES is a medical device that received FDA 510(k) clearance on 2004-06-01. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K040395.

When did CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES receive FDA 510(k) clearance?

CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES received FDA 510(k) clearance on 2004-06-01, under 510(k) number K040395.

Who is the listed applicant for CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES?

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 CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES?

The FDA product code for CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES is MHX.

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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.