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FDA 510(k)

BSM-2100A CONFIGURED PATIENT MONITOR

K-Number: K914092 · 1992-05-28

ApplicantNihon Kohden America, Inc.
Decision Date1992-05-28
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BSM-2100A CONFIGURED PATIENT MONITOR 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 1992-05-28 under 510(k) number K914092. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BSM-2100A CONFIGURED PATIENT MONITOR?

BSM-2100A CONFIGURED PATIENT MONITOR is a medical device that received FDA 510(k) clearance on 1992-05-28. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K914092.

When did BSM-2100A CONFIGURED PATIENT MONITOR receive FDA 510(k) clearance?

BSM-2100A CONFIGURED PATIENT MONITOR received FDA 510(k) clearance on 1992-05-28, under 510(k) number K914092.

Who is the listed applicant for BSM-2100A CONFIGURED PATIENT MONITOR?

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 BSM-2100A CONFIGURED PATIENT MONITOR?

The FDA product code for BSM-2100A CONFIGURED PATIENT MONITOR is DSI.

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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: DSI)

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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

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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