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FDA 510(k)

BSM-8800A BEDSIDE MONITOR

K-Number: K944422 · 1995-05-24

ApplicantNihon Kohden America, Inc.
Decision Date1995-05-24
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BSM-8800A BEDSIDE 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 1995-05-24 under 510(k) number K944422. 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-8800A BEDSIDE MONITOR?

BSM-8800A BEDSIDE MONITOR is a medical device that received FDA 510(k) clearance on 1995-05-24. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K944422.

When did BSM-8800A BEDSIDE MONITOR receive FDA 510(k) clearance?

BSM-8800A BEDSIDE MONITOR received FDA 510(k) clearance on 1995-05-24, under 510(k) number K944422.

Who is the listed applicant for BSM-8800A BEDSIDE 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-8800A BEDSIDE MONITOR?

The FDA product code for BSM-8800A BEDSIDE 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.

K113117NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOXK120485NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT PK092573NIHON KOHDEN QP-160AK EEG TREND PROGRAMK083456NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970PK083271BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORYK082785NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES

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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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