510(k) K103242
K103242 is an FDA 510(k) premarket notification submitted by Redsense Medical AB for the device "REDSENSE-ALARM UNIT AND SENSOR". The FDA issued a decision of Substantially Equivalent on February 10, 2011. 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
- February 10, 2011
- Date Received
- November 2, 2010
- 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.