FDA 510(k)

ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A

K-Number: K030105 · 2003-03-04

Decision Date2003-03-04

Product CodeMHX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A 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 2003-03-04 under 510(k) number K030105. 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 ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A?

ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A is a medical device that received FDA 510(k) clearance on 2003-03-04. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K030105.

When did ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A receive FDA 510(k) clearance?

ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A received FDA 510(k) clearance on 2003-03-04, under 510(k) number K030105.

Who is the listed applicant for ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A?

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 ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A?

The FDA product code for ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A is MHX.

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Other records listing Nihon Kohden America, Inc. as applicant

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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.