The following data is part of a premarket notification filed by Getemed Medizin- Und Informationstechnik Ag with the FDA for Cardiomem Cm 3000-12.
| Device ID | K051686 |
| 510k Number | K051686 |
| Device Name: | CARDIOMEM CM 3000-12 |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
| Contact | Carolann Kotula |
| Correspondent | Carolann Kotula GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-23 |
| Decision Date | 2005-07-14 |
| Summary: | summary |