FDA.reportPublic FDA data

Innocor

Primary DI
05713867000056
Brand
Innocor
Company
Innovision ApS
Model
INN00400
Device description
Cardio-pulmonary function test & analysis equipment
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BZCCalculator, Pulmonary Function Data
BZGSpirometer, Diagnostic
DQKComputer, Diagnostic, Programmable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZCCalculator, Pulmonary Function DataAnesthesiology2
BZGSpirometer, DiagnosticAnesthesiology2
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051907000
K071911000
K083879000
K102047000

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
K102047000LCI OPTION FOR INNOCORInnovision A/S2011-11-01BZC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713867000056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713867000056057138670000565713867000056

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary function analysis system, adultA device used to measure the function of the respiratory system in adults and compliant children. It usually includes a spirometer with volume-sensing (e.g., rolling-seal, bellow) and flow-sensing (e.g., pneumotachometer) devices, a gas analyser for evaluation of absolute lung volumes and gas-diffusing capacity of the lungs, and computer capabilities for data processing and recording; a total-body plethysmograph to measure both lung volumes and airway resistance may be included. The device is mostly used for outpatient or presurgical screening, and may also be used in the diagnosis and evaluation of common diseases in older children [e.g., asthma, cystic fibrosis (CF), 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
05713867000063InnocorINN005002016-09-01
05713867000193InnocorINN00500-1c2017-03-14
05713867000100InnocorINN00010-12017-03-14
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
00851845007248comPAS2VITALOGRAPH (IRELAND) LIMITEDBZG2026-06-03
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.BZG2026-06-02
05415067055811EnSite™ST. JUDE MEDICAL, INC.DQK2026-06-01
08719689142124QMAPP Fysicon B.V.DQK2026-05-19
08719689142131QMAPP Fysicon B.V.DQK2026-05-19
08719689142162QMAPP Fysicon B.V.DQK2026-05-19
08719689142179QMAPP Fysicon B.V.DQK2026-05-19
07640142190554EasyOne Sky SpirometerNDD Medizintechnik AGBZG2026-04-21
08052990320288MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320295MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320318MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320325MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320363MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320370MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320387MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320431MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320455MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320462MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320479MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320509MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320516MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320547MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320554MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320561MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990320585MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08052990322022MIRMIR MEDICAL INTERNATIONAL RESEARCH SPABZG2026-04-03
08800069700109AT-ReportATsens Co., Ltd.DQK2025-11-05
08800069700246ATACC-C130AATsens Co., Ltd.DQK2025-11-05
08800069700260AT-PatchATsens Co., Ltd.DQK2025-11-05
08800069700277AT-PatchATsens Co., Ltd.DQK2025-11-05