FDA.reportPublic FDA data

Innocor

Primary DI
05713867000001
Brand
Innocor
Company
Innovision ApS
Model
INN00010
Device description
Innocor Cardio-pulmonary function test 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
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
05713867000001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713867000001057138670000015713867000001

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary stress exercise monitoring systemAn assembly of devices intended to noninvasively assess the cardiopulmonary response to exercise or measure of energy expenditure using indirect calorimetry. Breath by breath measurements of flow, oxygen (O2) uptake, and carbon dioxide (CO2) production are performed by O2 and CO2 analysers during exercise, along with the measurement of vital parameters. A mask, mouthpiece, or hood is attached to tubing and connected from the patient to the gas analysers while exercise is being performed using a particular device (e.g., an ergometer). The system typically monitors functions [e.g., provides continuous electrocardiogram (ECG)], provides control of the workload, and displays and prints results.

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
05713867000018InnocorINN003002016-09-01
05713867000025InnocorINN001002016-09-01
05713867000056InnocorINN004002016-09-01
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

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Primary DI, Brand, Company table
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