REDSENSE
Autonomous Extracorporeal Blood Leak Detector/alarm
REDSENSE MEDICAL AB
The following data is part of a premarket notification filed by Redsense Medical Ab with the FDA for Redsense.
Pre-market Notification Details
| Device ID | K071013 |
| 510k Number | K071013 |
| Device Name: | REDSENSE |
| Classification | Autonomous Extracorporeal Blood Leak Detector/alarm |
| Applicant | REDSENSE MEDICAL AB 6470 RIVERVIEW TERRACE Fridley, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy REDSENSE MEDICAL AB 6470 RIVERVIEW TERRACE 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 | 2007-04-10 |
| Decision Date | 2007-10-18 |
| Summary: | summary |
Trademark Results [REDSENSE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REDSENSE 86210735 4843727 Live/Registered |
Redsense Medical AB 2014-03-04 |
 REDSENSE 77103041 3911345 Dead/Cancelled |
REDSENSE MEDICAL AB 2007-02-08 |
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