INNOCOR

Computer, Diagnostic, Programmable

INNOVISION A/S

The following data is part of a premarket notification filed by Innovision A/s with the FDA for Innocor.

Pre-market Notification Details

• Device ID: K051907
• 510k Number: K051907
• Device Name: INNOCOR
• Classification: Computer, Diagnostic, Programmable
• Applicant: INNOVISION A/S 70 W. MADISON ST., STE 3300 Chicago, IL 60602
• Contact: Richard O Wood
• Correspondent: Richard O Wood; INNOVISION A/S 70 W. MADISON ST., STE 3300 Chicago, IL 60602
• Product Code: DQK
• CFR Regulation Number: 870.1425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-07-14
• Decision Date: 2006-03-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05713867000193	K051907	000
05713867000018	K051907	000
05713867000025	K051907	000
05713867000056	K051907	000
05713867000063	K051907	000
05713867000100	K051907	000
05713867000124	K051907	000
05713867000148	K051907	000
05713867000155	K051907	000
05713867000162	K051907	000
05713867000179	K051907	000
05713867000186	K051907	000
05713867000001	K051907	000