510(k) K071013
K071013 is an FDA 510(k) premarket notification submitted by Redsense Medical AB for the device "REDSENSE". The FDA issued a decision of Substantially Equivalent on October 18, 2007. The device falls under product code ODX (Autonomous Extracorporeal Blood Leak Detector/Alarm), a Class II device regulated under 21 CFR 876.5820. Redsense Medical AB has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2007
- Date Received
- April 10, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Autonomous Extracorporeal Blood Leak Detector/Alarm
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type
To detect the presence of blood leaking from an extracorporeal connection or needle site in hemodialysis patients and alert the user or attending staff. The device detects colormetric, chemical, or light modulation caused by exposure to leaking blood.