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FDA 510(k)

MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM

K-Number: K061741 · 2006-09-15

ApplicantGE Healthcare
Decision Date2006-09-15
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2006-09-15 under 510(k) number K061741. 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 /COMBOLAB/SPECIALSLAB SYSTEM?

MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM is a medical device that received FDA 510(k) clearance on 2006-09-15. The listed applicant is GE Healthcare. The 510(k) number is K061741.

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

MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM received FDA 510(k) clearance on 2006-09-15, under 510(k) number K061741.

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

The FDA 510(k) record lists GE Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM?

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

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Other records listing GE Healthcare 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.

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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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