FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REDSENSE
K Number: K071013
·
Decision Oct 18, 2007
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
3
Applicant Total
4
Review Days
191
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Basic Information
- Device Name
- REDSENSE
- K Number
- K071013
- 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
- April 10, 2007
- Decision Date
- October 18, 2007
- 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 |
Similar 510(k) Clearances
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REDSENSE ALARM SYSTEM
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REDSENSE-HOME USE
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