The following data is part of a premarket notification filed by Getemed Medizin- Und Informationstechnik Ag with the FDA for Cardioday V2.5.
| Device ID | K162023 |
| 510k Number | K162023 |
| Device Name: | CardioDay V2.5 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG ODERSTR. 77 Teltow, DE 14513 |
| Contact | Bert Schadow |
| Correspondent | Bert Schadow GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG ODERSTR. 77 Teltow, 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 | 2016-07-22 |
| Decision Date | 2017-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250903200144 | K162023 | 000 |
| 04250903202445 | K162023 | 000 |
| 04250903202469 | K162023 | 000 |
| 04250903202520 | K162023 | 000 |