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FDA 510(k)

Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX

K-Number: K213972 · 2022-02-17

ApplicantGe Healthcare Information Technologies, Inc.
Decision Date2022-02-17
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare Information Technologies, Inc.. It received FDA 510(k) clearance on 2022-02-17 under 510(k) number K213972. 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 Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX?

Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX is a medical device that received FDA 510(k) clearance on 2022-02-17. The listed applicant is Ge Healthcare Information Technologies, Inc.. The 510(k) number is K213972.

When did Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX receive FDA 510(k) clearance?

Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX received FDA 510(k) clearance on 2022-02-17, under 510(k) number K213972.

Who is the listed applicant for Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX?

The FDA 510(k) record lists Ge Healthcare Information Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX?

The FDA product code for Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX is DQK.

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.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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