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Innocor

FDA UDI

Class II (US FDA UDI)

by Innovision ApS

Identity

Trade Name
Innocor FDA UDI
Generic Name
Cardiopulmonary stress exercise monitoring system FDA UDI
Device Name
Innocor Cardio-pulmonary function test equipment FDA UDI
Model / Reference
INN00010 FDA UDI
Description
Innocor Cardio-pulmonary function test equipment FDA UDI

Identifiers

Primary DI / UDI-DI
05713867000001 FDA UDI
510(k) Number
K051907 FDA UDI
K071911 FDA UDI
K083879 FDA UDI
FDA Product Code
BZG FDA UDI
DQK FDA UDI
GMDN Term
Cardiopulmonary stress exercise monitoring system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1840 FDA UDI
870.1425 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Pulmonary function analysis system, adultCardiopulmonary stress exercise monitoring systemPulmonary function analysis system, paediatric

Innocor by Innovision ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pulmonary function analysis system, paediatric.

Cleared under the same submission

K051907 also covers:

K071911 also covers:

K083879 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Innovision ApS

Sources (1)

  • FDA UDI 807fe87a-71f8-4b41-aa45-ec25214ecc61 34 fields · synced Jun 8, 2026