The following data is part of a premarket notification filed by Corscience Gmbh & Co. with the FDA for Cor12 Ecg.
| Device ID | K183369 |
| 510k Number | K183369 |
| Device Name: | COR12 ECG |
| Classification | Electrocardiograph |
| Applicant | Corscience GmbH & Co. Hartmannstrasse 65 Erlangen, DE D-91052 |
| Contact | Karlheinz Trost |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-12-04 |
| Decision Date | 2018-12-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251341900245 | K183369 | 000 |
| 04251341900238 | K183369 | 000 |
| 04251341900115 | K183369 | 000 |
| 04251341900108 | K183369 | 000 |
| 04251341900344 | K183369 | 000 |
| 04251341900252 | K183369 | 000 |