The following data is part of a premarket notification filed by Viasys Healthcare Gmbh with the FDA for Cor12+.
| Device ID | K091505 |
| 510k Number | K091505 |
| Device Name: | COR12+ |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | VIASYS HEALTHCARE GMBH LEIBNIZSTRASSE 7 Hoechberg, DE 97204 |
| Contact | Thomas Rust |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-05-21 |
| Decision Date | 2009-06-10 |
| Summary: | summary |