The following data is part of a premarket notification filed by Coramed Technologies, Llc with the FDA for Cora (coagulation Resonance Analysis) System.
| Device ID | K150041 |
| 510k Number | K150041 |
| Device Name: | CORA (Coagulation Resonance Analysis) System |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| 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 | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-09 |
| Decision Date | 2015-06-26 |
| Summary: | summary |