FDA.reportPublic FDA data

Innocor

Primary DI
05713867000100
Brand
Innocor
Company
Innovision ApS
Model
INN00010-1
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
BZGSpirometer, Diagnostic
DQKComputer, Diagnostic, Programmable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051907000
K071911000
K083879000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051907000INNOCORInnovision A/S2006-03-02DQK
K071911000CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCORInnovision A/S2007-09-07DQK
K083879000INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500)Innovision A/S2009-02-23BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713867000100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713867000100057138670001005713867000100

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
05713867000124InnocorINN00100-12017-03-14
05713867000148InnocorINN00300-12017-03-14
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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00198953213094Mac-LabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953243626MLCL Client SoftwareGe Medical Systems Information Technologies, Inc.DQK2026-08-26
05415067055651EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055668EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055675EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055682EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
04057155000924SpiroWayeResearchTechnology GmbHBZG2026-08-14
00885403532040FloTracBecton, Dickinson And CompanyDQK2026-07-31
09349714010877MICROPACE PTY LIMITEDMICROPACE PTY LIMITEDDQK2026-07-21
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17540262170054Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2026-07-21
05056845200278Spiroguard Noseclip-Cheek holderGVS FILTER TECHNOLOGY UK LTDBZG2026-06-26
00884838118898IECGPhilips Medizin Systeme Böblingen GmbHDQK2026-06-23
00851845007248comPAS2VITALOGRAPH (IRELAND) LIMITEDBZG2026-06-03
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.BZG2026-06-02
05415067055811EnSite™ST. JUDE MEDICAL, INC.DQK2026-06-01
00854277008197NorthStar Mapping SystemImricor Medical Systems, Inc.DQK2026-05-21
07640142190554EasyOne Sky SpirometerNDD Medizintechnik AGBZG2026-04-21
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08052990320370MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
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