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: K051471
• 510k Number: K051471
• Device Name: CARDIODAY
• Classification: Computer, Diagnostic, Programmable
• Applicant: GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG 55 Northern Blvd Suite 200 Great Neck, NY 11021
• Contact: Bert Schadow
• Correspondent: Tamas Borsai; TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470
• Product Code: DQK
• CFR Regulation Number: 870.1425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2005-06-03
• Decision Date: 2005-06-29
• Summary: summary