SpectraWAVE Imaging System— 510(k) K221257
Substantially EquivalentSpectrawave, Inc.
FDA 510(k) clearance K221257 for SpectraWAVE Imaging System, Substantially Equivalent on 2023-02-28. Applicant: Spectrawave, Inc.. Device class: 2.
Clearance details
- Applicant
- Spectrawave, Inc.
- 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
- Bedford, MA, US
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