FDA 510(k)

PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION

K-Number: K073550 · 2008-03-28

Decision Date2008-03-28

Product CodeMHX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION 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 2008-03-28 under 510(k) number K073550. 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 PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION?

PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION is a medical device that received FDA 510(k) clearance on 2008-03-28. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K073550.

When did PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION receive FDA 510(k) clearance?

PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION received FDA 510(k) clearance on 2008-03-28, under 510(k) number K073550.

Who is the listed applicant for PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION?

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 PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION?

The FDA product code for PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION is MHX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.