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FDA 510(k)

NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES

K-Number: K082785 · 2008-11-26

ApplicantNihon Kohden America, Inc.
Decision Date2008-11-26
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A 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 2008-11-26 under 510(k) number K082785. 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 NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES?

NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES is a medical device that received FDA 510(k) clearance on 2008-11-26. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K082785.

When did NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES receive FDA 510(k) clearance?

NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES received FDA 510(k) clearance on 2008-11-26, under 510(k) number K082785.

Who is the listed applicant for NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A 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 NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES?

The FDA product code for NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES is MHX.

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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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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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