OPUSWAVE Dual Sensor Imaging System— 510(k) K250684
Substantially EquivalentTerumo Cardiovascular Systems Thi Plant
FDA 510(k) clearance K250684 for OPUSWAVE Dual Sensor Imaging System, Substantially Equivalent on 2025-07-02. Applicant: Terumo Cardiovascular Systems Thi Plant. Device class: 2.
Clearance details
- Applicant
- Terumo Cardiovascular Systems Thi Plant
- Product code
- Code NQQ
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ann Arbor, MI, US
Recent devices under product code NQQ
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