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Medisono Color Doppler Ultrasound System (P11 Portable +5 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K170078
Identifiers
- 510(k) Number
- K170078 FDA 510(k)
- FDA Product Code
- IYN FDA 510(k)
- Models / Variants
- P11 Portable FDA 510(k)P11 EXPERT Portable FDA 510(k)P12 Trolley FDA 510(k)P12 Expert FDA 510(k)P25 Trolley FDA 510(k)P25 Expert Trolley FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1550 FDA 510(k)
- Regulation Number
- 892.1550 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Medisono Color Doppler Ultrasound System (P11 Portable +5 more) by Medisono, LLC — Class II — FDA_510K — listed in FDA 510(k) — 6 models
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170078 | Class II | Active |
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Manufacturer
- Manufacturer
- Medisono, LLC
Sources (1)
- FDA 510(k) K170078 24 fields · synced Jun 18, 2026