The following data is part of a premarket notification filed by Getemed Medizin- Und Informationstechnik Ag with the FDA for Cardioday, Version 2.0.
Device ID | K070280 |
510k Number | K070280 |
Device Name: | CARDIODAY, VERSION 2.0 |
Classification | Computer, Diagnostic, Programmable |
Applicant | GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
Contact | Romil Rambhia |
Correspondent | Romil Rambhia GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
Product Code | DQK |
CFR Regulation Number | 870.1425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-01-29 |
Decision Date | 2007-02-23 |
Summary: | summary |