CARDIOMEM
Electrocardiograph, Ambulatory (without Analysis)
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
The following data is part of a premarket notification filed by Getemed Medizin- Und Informationstechnik Ag with the FDA for Cardiomem.
Pre-market Notification Details
| Device ID | K122272 |
| 510k Number | K122272 |
| Device Name: | CARDIOMEM |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk 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 | 2012-07-30 |
| Decision Date | 2013-03-28 |
| Summary: | summary |
Trademark Results [CARDIOMEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CARDIOMEM 79018793 not registered Dead/Abandoned |
getemed Medizin- und Informationstechnik AG 2005-08-04 |
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