MIDA ALGORITHM REV. B— 510(k) K023414
Substantially EquivalentOrtivus AB
FDA 510(k) clearance K023414 for MIDA ALGORITHM REV. B, Substantially Equivalent on 2003-12-05. Applicant: Ortivus AB. Device class: 2.
Clearance details
- Applicant
- Ortivus AB
- Product code
- Code DYC
- Device class
- Class 2
- Regulation
- 21 CFR 870.2400
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taby, SE
Recent devices under product code DYC
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