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FDA 510(k)

MAC-LAB/CARDIOLAB EP/COMBOLAB

K-Number: K021366 · 2002-07-03

ApplicantGeneral Electric Medical Systems Information Techn
Decision Date2002-07-03
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MAC-LAB/CARDIOLAB EP/COMBOLAB 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 2002-07-03 under 510(k) number K021366. 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/CARDIOLAB EP/COMBOLAB?

MAC-LAB/CARDIOLAB EP/COMBOLAB is a medical device that received FDA 510(k) clearance on 2002-07-03. The listed applicant is General Electric Medical Systems Information Techn. The 510(k) number is K021366.

When did MAC-LAB/CARDIOLAB EP/COMBOLAB receive FDA 510(k) clearance?

MAC-LAB/CARDIOLAB EP/COMBOLAB received FDA 510(k) clearance on 2002-07-03, under 510(k) number K021366.

Who is the listed applicant for MAC-LAB/CARDIOLAB EP/COMBOLAB?

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/CARDIOLAB EP/COMBOLAB?

The FDA product code for MAC-LAB/CARDIOLAB EP/COMBOLAB is DQK.

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Other records listing General Electric Medical Systems Information Techn as applicant

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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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