Innovision, Inc.
Omaha, NE, US
Innovision, Inc. appears in FDA device records in Omaha, NE. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Innovision, Inc. between 1994 and 2015. The busiest year on record is 2011, with 2. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 2000 | 1 |
| 2001 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2009 | 1 |
| 2011 | 2 |
| 2014 | 1 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K151146 | N-Force Fixation System | HWC | Substantially Equivalent | |
| K132244 | N-FORCE FIXATION SYSTEM | HWC | Substantially Equivalent | |
| K102047 | LCI OPTION FOR INNOCOR | BZC | Substantially Equivalent | |
| K102528 | N-FORCE FIXATION SYSTEM | HWC | Substantially Equivalent | |
| K083879 | INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500) | BZG | Substantially Equivalent | |
| K071911 | CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR | DQK | Substantially Equivalent | |
| K051907 | INNOCOR | DQK | Substantially Equivalent | |
| K011914 | HYDRO2, HS-75 | HQD | Substantially Equivalent | |
| K000485 | HYDRO2, HS-75 | HQD | Substantially Equivalent | |
| K944223 | ACCUCON | HQD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2769-2016 | Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters. | The purpose of the recall is to replace data transmission cable (USB-cable) connecting the lnnocor device with an external computer. The replacement USB cable will provide galvanic isolation of the lnnocor from the external computer via opto-couplers, as opposed to the grounding protection currently in use. The replacement is intended to prevent risk of electric shock. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain