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FDA 510(k)

CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR

K-Number: K071911 · 2007-09-07

ApplicantInnovision A/S
Decision Date2007-09-07
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOPULMONARY EXERCISE TESTING OPTION TO 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 2007-09-07 under 510(k) number K071911. 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 CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR?

CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR is a medical device that received FDA 510(k) clearance on 2007-09-07. The listed applicant is Innovision A/S. The 510(k) number is K071911.

When did CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR receive FDA 510(k) clearance?

CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR received FDA 510(k) clearance on 2007-09-07, under 510(k) number K071911.

Who is the listed applicant for CARDIOPULMONARY EXERCISE TESTING OPTION TO 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 CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR?

The FDA product code for CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR is DQK.

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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)K051907INNOCOR

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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