Cardiopulmonary Exercise Testing Option to Innocor

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K071911 ↗

FDA Product Code

DQK

Device Class

Class II

Regulation

21 CFR Part 870.1425

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath System (INN00400), Nibp(INN00500)

  Class II

  FDA 510(k) K083879 Active Cleared 23 Feb 2009

• Innocor

  Class II

  FDA 510(k) K051907 Active Cleared 2 Mar 2006

• Lci Option for Innocor

  Class II

  FDA 510(k) K102047 Active Cleared 1 Nov 2011

• What is the Cardiopulmonary Exercise Testing Option to Innocor used for?

  This module is designed to enable non-invasive measurement of respiratory parameters during exercise testing. It attaches to the Innocor system and provides breath-by-breath analysis of respiratory flow and gas concentrations (oxygen uptake and carbon dioxide production). Clinicians use it to assess metabolic responses during cardiopulmonary exercise testing, particularly in settings requiring hemodynamic and metabolic monitoring.

• How is the Cardiopulmonary Exercise Testing Option to Innocor supplied and used?

  The device is supplied as an add-on module for the Innocor system. It requires a pneumotachometer placed between a respiratory valve and the patient to function. The module itself is intended for single-use or reusable applications, though specific sterility or reuse guidelines must be followed as per Innovision’s instructions.

• Is this device approved for MRI environments?

  The provided data does not mention MRI safety or compatibility for this device. If MRI use is required, additional verification or documentation from Innovision A/S should be consulted to ensure safe operation.

• What regulatory approval does this device hold?

  The Cardiopulmonary Exercise Testing Option to Innocor has been cleared by the FDA under 510(k) number K071911, demonstrating substantial equivalence to the Medical Graphics Ultima System. This clearance is specific to its intended use in cardiopulmonary exercise testing.

• Are there specific storage requirements for this module?

  The data does not specify any particular storage requirements for the Cardiopulmonary Exercise Testing Option to Innocor. However, standard environmental controls (e.g., temperature, humidity) for medical devices should be followed to maintain functionality and integrity until use.