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FDA 510(k)

INNOCOR

K-Number: K051907 · 2006-03-02

ApplicantInnovision A/S
Decision Date2006-03-02
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INNOCOR is the device name listed in this FDA 510(k) record. The listed applicant is Innovision A/S. It received FDA 510(k) clearance on 2006-03-02 under 510(k) number K051907. 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 INNOCOR?

INNOCOR is a medical device that received FDA 510(k) clearance on 2006-03-02. The listed applicant is Innovision A/S. The 510(k) number is K051907.

When did INNOCOR receive FDA 510(k) clearance?

INNOCOR received FDA 510(k) clearance on 2006-03-02, under 510(k) number K051907.

Who is the listed applicant for INNOCOR?

The FDA 510(k) record lists Innovision A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INNOCOR?

The FDA product code for INNOCOR 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Innovision A/S 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.

K102047LCI OPTION FOR INNOCORK083879INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500)K071911CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR

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

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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