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FDA 510(k)

CARDIOSTATION-100 (CS-100)

K-Number: K041031 · 2005-01-26

ApplicantUs Clover Co.
Decision Date2005-01-26
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOSTATION-100 (CS-100) is the device name listed in this FDA 510(k) record. The listed applicant is Us Clover Co.. It received FDA 510(k) clearance on 2005-01-26 under 510(k) number K041031. 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 CARDIOSTATION-100 (CS-100)?

CARDIOSTATION-100 (CS-100) is a medical device that received FDA 510(k) clearance on 2005-01-26. The listed applicant is Us Clover Co.. The 510(k) number is K041031.

When did CARDIOSTATION-100 (CS-100) receive FDA 510(k) clearance?

CARDIOSTATION-100 (CS-100) received FDA 510(k) clearance on 2005-01-26, under 510(k) number K041031.

Who is the listed applicant for CARDIOSTATION-100 (CS-100)?

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

What is the FDA product code for CARDIOSTATION-100 (CS-100)?

The FDA product code for CARDIOSTATION-100 (CS-100) is DQK.

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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

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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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