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FDA 510(k)

GALIX WINTER

K-Number: K030145 · 2003-09-17

ApplicantGalix Biomedical Instrumentation, Inc.
Decision Date2003-09-17
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GALIX WINTER 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 2003-09-17 under 510(k) number K030145. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALIX WINTER?

GALIX WINTER is a medical device that received FDA 510(k) clearance on 2003-09-17. The listed applicant is Galix Biomedical Instrumentation, Inc.. The 510(k) number is K030145.

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

GALIX WINTER received FDA 510(k) clearance on 2003-09-17, under 510(k) number K030145.

Who is the listed applicant for GALIX WINTER?

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 WINTER?

The FDA product code for GALIX WINTER is DQK.

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 STATIONK023080GALIX PACESTARK992706GALIX GBI -3S-LPK9716703 CHANNEL DIGITAL AMBULATORY ECG RECORDER

Related Devices (Code: DQK)

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.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

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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