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FDA 510(k)

GALIX PACESTAR

K-Number: K023080 · 2003-06-11

ApplicantGalix Biomedical Instrumentation, Inc.
Decision Date2003-06-11
Product CodeDTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GALIX PACESTAR 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 2003-06-11 under 510(k) number K023080. The device is classified under product code DTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALIX PACESTAR?

GALIX PACESTAR is a medical device that received FDA 510(k) clearance on 2003-06-11. The listed applicant is Galix Biomedical Instrumentation, Inc.. The 510(k) number is K023080.

When did GALIX PACESTAR receive FDA 510(k) clearance?

GALIX PACESTAR received FDA 510(k) clearance on 2003-06-11, under 510(k) number K023080.

Who is the listed applicant for GALIX PACESTAR?

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 PACESTAR?

The FDA product code for GALIX PACESTAR is DTE.

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-3SMK051163GALIX ECG PROFESSIONAL STATIONK030145GALIX WINTERK992706GALIX GBI -3S-LPK9716703 CHANNEL DIGITAL AMBULATORY ECG RECORDER

Related Devices (Code: DTE)

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.

K241781Solo Pace ControlSolo Pace, Inc.K232721Lifetech Cardio Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.K201011Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.K190825Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.K182839Lifetech Cardio Model 8301 Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.K181973Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.

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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