CORSCREEN
Electrocardiograph
VIASYS HEALTHCARE GMBH
The following data is part of a premarket notification filed by Viasys Healthcare Gmbh with the FDA for Corscreen.
Pre-market Notification Details
| Device ID | K070614 |
| 510k Number | K070614 |
| Device Name: | CORSCREEN |
| Classification | Electrocardiograph |
| Applicant | VIASYS HEALTHCARE GMBH LEIBNIZSTRASSE 7 Hoechberg, DE 97204 |
| Contact | Detlef Grotheer |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-03-05 |
| Decision Date | 2007-05-04 |
| Summary: | summary |
Trademark Results [CORSCREEN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CORSCREEN 77144045 3920010 Dead/Cancelled |
CAREFUSION GERMANY 234 GMBH 2007-03-29 |
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