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 |