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FDA 510(k)

AMBULATORY (HOLTER) RECORDING, MODIFICATION

K-Number: K922027 · 1993-02-17

ApplicantBiosensor Corp.
Decision Date1993-02-17
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMBULATORY (HOLTER) RECORDING, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Biosensor Corp.. It received FDA 510(k) clearance on 1993-02-17 under 510(k) number K922027. 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, MODIFICATION?

AMBULATORY (HOLTER) RECORDING, MODIFICATION is a medical device that received FDA 510(k) clearance on 1993-02-17. The listed applicant is Biosensor Corp.. The 510(k) number is K922027.

When did AMBULATORY (HOLTER) RECORDING, MODIFICATION receive FDA 510(k) clearance?

AMBULATORY (HOLTER) RECORDING, MODIFICATION received FDA 510(k) clearance on 1993-02-17, under 510(k) number K922027.

Who is the listed applicant for AMBULATORY (HOLTER) RECORDING, MODIFICATION?

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, MODIFICATION?

The FDA product code for AMBULATORY (HOLTER) RECORDING, MODIFICATION 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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