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FDA 510(k)

BEDSIDE MONITOR, MODEL OPV-1500

K-Number: K032749 · 2003-09-16

ApplicantNihon Kohden America, Inc.
Decision Date2003-09-16
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BEDSIDE MONITOR, MODEL OPV-1500 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 2003-09-16 under 510(k) number K032749. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEDSIDE MONITOR, MODEL OPV-1500?

BEDSIDE MONITOR, MODEL OPV-1500 is a medical device that received FDA 510(k) clearance on 2003-09-16. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K032749.

When did BEDSIDE MONITOR, MODEL OPV-1500 receive FDA 510(k) clearance?

BEDSIDE MONITOR, MODEL OPV-1500 received FDA 510(k) clearance on 2003-09-16, under 510(k) number K032749.

Who is the listed applicant for BEDSIDE MONITOR, MODEL OPV-1500?

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 BEDSIDE MONITOR, MODEL OPV-1500?

The FDA product code for BEDSIDE MONITOR, MODEL OPV-1500 is MWI.

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Other records listing Nihon Kohden America, Inc. as applicant

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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Related Devices (Code: MWI)

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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