The following data is part of a premarket notification filed by Redsense Medical Ab with the FDA for Redsense-home Use.
| Device ID | K092955 |
| 510k Number | K092955 |
| Device Name: | REDSENSE-HOME USE |
| Classification | Autonomous Extracorporeal Blood Leak Detector/alarm |
| Applicant | REDSENSE MEDICAL AB 435 RICE CREEK TERRANCE Fridley, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy REDSENSE MEDICAL AB 435 RICE CREEK TERRANCE Fridley, MN 55432 |
| Product Code | ODX |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-25 |
| Decision Date | 2010-05-10 |
| Summary: | summary |