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FDA 510(k)

AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED

K-Number: K895266 · 1990-01-26

ApplicantBiosensor Corp.
Decision Date1990-01-26
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Biosensor Corp.. It received FDA 510(k) clearance on 1990-01-26 under 510(k) number K895266. 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 AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED?

AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED is a medical device that received FDA 510(k) clearance on 1990-01-26. The listed applicant is Biosensor Corp.. The 510(k) number is K895266.

When did AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED receive FDA 510(k) clearance?

AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED received FDA 510(k) clearance on 1990-01-26, under 510(k) number K895266.

Who is the listed applicant for AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED?

The FDA 510(k) record lists Biosensor Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED?

The FDA product code for AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED is DSI.

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Other records listing Biosensor Corp. 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.

K990956BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005K974546BIOSENSOR HOLTER MONITOR SYSTEMK974192BIOSENSOR HOLTER MONITOR SYSTEMK950944AMBULATORY (HOLTER) RECORDING SYSTEMK960449PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90)K943338BIOSENSOR BIDOP VASCULAR TEST SYSTEM

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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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