FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇴 Norway
Re:Balans
K Number: K243727
·
Decision Oct 16, 2025
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
113
Applicant Total
1
Review Days
317
Basic Information
- Device Name
- Re:Balans
- K Number
- K243727
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mode Sensors AS
- Date Received
- December 3, 2024
- Decision Date
- October 16, 2025
- Product Code
- DSB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DSB | Plethysmograph, Impedance | FDA class 2 | Cardiovascular |
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