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FDA 510(k)

3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM

K-Number: K092853 · 2010-07-09

ApplicantGalix Biomedical Instrumentation, Inc.
Decision Date2010-07-09
Product CodeMLO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM is the device name listed in this FDA 510(k) record. The listed applicant is Galix Biomedical Instrumentation, Inc.. It received FDA 510(k) clearance on 2010-07-09 under 510(k) number K092853. The device is classified under product code MLO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM?

3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM is a medical device that received FDA 510(k) clearance on 2010-07-09. The listed applicant is Galix Biomedical Instrumentation, Inc.. The 510(k) number is K092853.

When did 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM receive FDA 510(k) clearance?

3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM received FDA 510(k) clearance on 2010-07-09, under 510(k) number K092853.

Who is the listed applicant for 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM?

The FDA 510(k) record lists Galix Biomedical Instrumentation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM?

The FDA product code for 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM is MLO.

Related Clinical Trials

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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Other records listing Galix Biomedical Instrumentation, 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.

K051163GALIX ECG PROFESSIONAL STATIONK030145GALIX WINTERK023080GALIX PACESTARK992706GALIX GBI -3S-LPK9716703 CHANNEL DIGITAL AMBULATORY ECG RECORDER

Related Devices (Code: MLO)

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.

K261580ZBPro Diagnostic (Version 2.0)Zbeats, Inc.K241890Philips Holter Analysis SystemPhilips Medizin Systeme Böblingen GmbHK240794Frontier X PlusFourth Frontier Technologies Pvt, Ltd.K200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.K193177CER-SCardiocalmK182030Faros MobileBittium Biosignals , Ltd.

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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