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FDA 510(k)

LCI OPTION FOR INNOCOR

K-Number: K102047 · 2011-11-01

ApplicantInnovision A/S
Decision Date2011-11-01
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LCI OPTION FOR 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 2011-11-01 under 510(k) number K102047. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LCI OPTION FOR INNOCOR?

LCI OPTION FOR INNOCOR is a medical device that received FDA 510(k) clearance on 2011-11-01. The listed applicant is Innovision A/S. The 510(k) number is K102047.

When did LCI OPTION FOR INNOCOR receive FDA 510(k) clearance?

LCI OPTION FOR INNOCOR received FDA 510(k) clearance on 2011-11-01, under 510(k) number K102047.

Who is the listed applicant for LCI OPTION 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 LCI OPTION FOR INNOCOR?

The FDA product code for LCI OPTION FOR INNOCOR is BZC.

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 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.

K083879INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500)K071911CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCORK051907INNOCOR

Related Devices (Code: BZC)

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.

K240293STSTechbopulm, Ltd.K183567Vyntus/SentrySuite Product LineVyaire MedicalK190853Vyntus BODYVyaire Medical, Inc.K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CARTVyaire Medical, Inc.K162515COSMED K5 Wearable Metabolic TechnologyCosmed SrlK161295MiniBox +Pulmone Advanced Medical Devices, Ltd.

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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