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FDA 510(k)

CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM

K-Number: K103678 · 2011-02-16

ApplicantGe Medical Systems Information Technologies GmbH
Decision Date2011-02-16
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies GmbH. It received FDA 510(k) clearance on 2011-02-16 under 510(k) number K103678. 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 CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM?

CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-02-16. The listed applicant is Ge Medical Systems Information Technologies GmbH. The 510(k) number is K103678.

When did CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM receive FDA 510(k) clearance?

CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM received FDA 510(k) clearance on 2011-02-16, under 510(k) number K103678.

Who is the listed applicant for CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM?

The FDA 510(k) record lists Ge Medical Systems Information Technologies GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM?

The FDA product code for CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM is DQK.

Related Clinical Trials

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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Other records listing Ge Medical Systems Information Technologies GmbH as applicant

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.

K091594HEART-EXERCISEK000638RESPONDER 3000

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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