The following data is part of a premarket notification filed by Coramed Technologies, Llc with the FDA for Cora (coagulation Resonance Analysis) System With Platelet Mapping Assay.
| Device ID | K140893 |
| 510k Number | K140893 |
| Device Name: | CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY |
| Classification | System, Automated Platelet Aggregation |
| Applicant | CORAMED TECHNOLOGIES, LLC 6225 W. HOWARD ST. Niles, IL 60714 |
| Contact | Norman E Brunner |
| Correspondent | Norman E Brunner CORAMED TECHNOLOGIES, LLC 6225 W. HOWARD ST. Niles, IL 60714 |
| Product Code | JOZ |
| CFR Regulation Number | 864.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-08 |
| Decision Date | 2015-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30812747018351 | K140893 | 000 |