FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
REDSENSE ALARM SYSTEM
K Number: K130554
·
Decision Nov 22, 2013
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
3
Applicant Total
4
Review Days
263
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Basic Information
- Device Name
- REDSENSE ALARM SYSTEM
- K Number
- K130554
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Redsense Medical AB
- Date Received
- March 4, 2013
- Decision Date
- November 22, 2013
- Product Code
- ODX
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ODX | Autonomous Extracorporeal Blood Leak Detector/Alarm | FDA class 2 | Gastroenterology, Urology |
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