FDA.reportPublic FDA data

Innocor

Primary DI
05713867000148
Brand
Innocor
Company
Innovision ApS
Model
INN00300-1
Device description
Innocor cardio-pulmonary function test equipment
Published
2017-03-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DQKComputer, Diagnostic, Programmable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051907000
K071911000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051907000INNOCORInnovision A/S2006-03-02DQK
K071911000CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCORInnovision A/S2007-09-07DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713867000148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713867000148057138670001485713867000148

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary function analysis system, paediatricA computerized instrument designed to assess lung volume, flow, and mechanical parameters (including airway compliance and resistance) in young children and infants. It is different from an adult version in absolute dimensions and in the special procedures required for adaption to the pediatric patient (e.g., use of a small constant-volume chamber in which the infant reclines for plethysmography, use of a pressure jacket to obtain forced exhalation); also, parameters that require subject cooperation (e.g., vital capacity, forced expiratory volume) can't be determined. The device is used for pulmonary function testing in diagnostic studies and for evaluation of diseases and chest deformities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
305276496
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05713867000001InnocorINN000102016-09-01
05713867000018InnocorINN003002016-09-01
05713867000025InnocorINN001002016-09-01
05713867000056InnocorINN004002016-09-01
05713867000063InnocorINN005002016-09-01
05713867000193InnocorINN00500-1c2017-03-14
05713867000100InnocorINN00010-12017-03-14
05713867000124InnocorINN00100-12017-03-14
05713867000155InnocorINN00400-1a2017-03-14
05713867000162InnocorINN00400-1b2017-03-14
05713867000179InnocorINN00400-1c2017-03-14
05713867000186InnocorINN00500-1a2017-03-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198953243626MLCL Client SoftwareGe Medical Systems Information Technologies, Inc.DQK2026-08-26
05415067055651EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
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17540262170054Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2026-07-21
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