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FDA 510(k)

CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD)

K-Number: K042849 · 2005-01-13

ApplicantCardiobiomedical Corporation
Decision Date2005-01-13
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD) is the device name listed in this FDA 510(k) record. The listed applicant is Cardiobiomedical Corporation. It received FDA 510(k) clearance on 2005-01-13 under 510(k) number K042849. 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 CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD)?

CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD) is a medical device that received FDA 510(k) clearance on 2005-01-13. The listed applicant is Cardiobiomedical Corporation. The 510(k) number is K042849.

When did CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD) receive FDA 510(k) clearance?

CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD) received FDA 510(k) clearance on 2005-01-13, under 510(k) number K042849.

Who is the listed applicant for CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD)?

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

What is the FDA product code for CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD)?

The FDA product code for CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD) is DQK.

Related Clinical Trials

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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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