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FDA 510(k)

MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM

K-Number: K001305 · 2000-06-27

ApplicantGeneral Electric Medical Systems Information Techn
Decision Date2000-06-27
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Medical Systems Information Techn. It received FDA 510(k) clearance on 2000-06-27 under 510(k) number K001305. 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 MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM?

MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM is a medical device that received FDA 510(k) clearance on 2000-06-27. The listed applicant is General Electric Medical Systems Information Techn. The 510(k) number is K001305.

When did MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM receive FDA 510(k) clearance?

MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM received FDA 510(k) clearance on 2000-06-27, under 510(k) number K001305.

Who is the listed applicant for MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM?

The FDA 510(k) record lists General Electric Medical Systems Information Techn as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM?

The FDA product code for MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM is DQK.

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Other records listing General Electric Medical Systems Information Techn 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.

K023380T-WAVE ALTERMANS (TWA) ALGORITHM OPTIONK021470SEER LIGHT COMPACT DIGITAL HOLTER RECORDERK023100ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTSK021454UNITY NETWORK IDK020290DASH 3000/4000 PATIENT MONITORK021366MAC-LAB/CARDIOLAB EP/COMBOLAB

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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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