The following data is part of a premarket notification filed by Getemed Medizin- Und Informationstechnik Ag with the FDA for Cardiomem Cm 3000-12bt.
| Device ID | K063042 |
| 510k Number | K063042 |
| Device Name: | CARDIOMEM CM 3000-12BT |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
| Contact | Sid Mathur |
| Correspondent | Sid Mathur 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-03 |
| Decision Date | 2007-05-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250903201189 | K063042 | 000 |
| 04250903201172 | K063042 | 000 |
| 04250903201165 | K063042 | 000 |
| 04250903201158 | K063042 | 000 |
| 04250903201738 | K063042 | 000 |
| 04250903201721 | K063042 | 000 |
| 04250903201714 | K063042 | 000 |
| 04250903201707 | K063042 | 000 |
| 00840682108201 | K063042 | 000 |