CARDIODAY

Computer, Diagnostic, Programmable

GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG

The following data is part of a premarket notification filed by Getemed Medizin- Und Informationstechnik Ag with the FDA for Cardioday.

Pre-market Notification Details

• Device ID: K130516
• 510k Number: K130516
• Device Name: CARDIODAY
• Classification: Computer, Diagnostic, Programmable
• Applicant: GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG ODERSTR. 77 Teltow, Brandenburg, DE 14513
• Contact: Bert Schadow
• Correspondent: Bert Schadow; GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG ODERSTR. 77 Teltow, Brandenburg, DE 14513
• Product Code: DQK
• CFR Regulation Number: 870.1425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-02-27
• Decision Date: 2013-08-23
• Summary: summary