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FDA 510(k)

GALIX ECG PROFESSIONAL STATION

K-Number: K051163 · 2006-01-31

ApplicantGalix Biomedical Instrumentation, Inc.
Decision Date2006-01-31
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GALIX ECG PROFESSIONAL STATION 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 2006-01-31 under 510(k) number K051163. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALIX ECG PROFESSIONAL STATION?

GALIX ECG PROFESSIONAL STATION is a medical device that received FDA 510(k) clearance on 2006-01-31. The listed applicant is Galix Biomedical Instrumentation, Inc.. The 510(k) number is K051163.

When did GALIX ECG PROFESSIONAL STATION receive FDA 510(k) clearance?

GALIX ECG PROFESSIONAL STATION received FDA 510(k) clearance on 2006-01-31, under 510(k) number K051163.

Who is the listed applicant for GALIX ECG PROFESSIONAL STATION?

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 GALIX ECG PROFESSIONAL STATION?

The FDA product code for GALIX ECG PROFESSIONAL STATION is DPS.

Related Clinical Trials

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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.

K0928533 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SMK030145GALIX WINTERK023080GALIX PACESTARK992706GALIX GBI -3S-LPK9716703 CHANNEL DIGITAL AMBULATORY ECG RECORDER

Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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