REDSENSE-HOME USE— 510(k) K092955
Substantially EquivalentRedsense Medical AB
FDA 510(k) clearance K092955 for REDSENSE-HOME USE, Substantially Equivalent on 2010-05-10. Applicant: Redsense Medical AB. Device class: 2.
Clearance details
- Applicant
- Redsense Medical AB
- Product code
- Code ODX
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fridley, MN, US
Recent devices under product code ODX
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