The following data is part of a premarket notification filed by Redsense Medical Ab with the FDA for Redsense Alarm System.
| Device ID | K130554 |
| 510k Number | K130554 |
| Device Name: | REDSENSE ALARM SYSTEM |
| Classification | Autonomous Extracorporeal Blood Leak Detector/alarm |
| Applicant | REDSENSE MEDICAL AB GYLLENHAMMARS VAG 26 Halmstad, SE 30292 |
| Contact | Patrik Byhmer |
| Correspondent | Patrik Byhmer REDSENSE MEDICAL AB GYLLENHAMMARS VAG 26 Halmstad, SE 30292 |
| Product Code | ODX |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-04 |
| Decision Date | 2013-11-22 |
| Summary: | summary |