HALO— 510(k) K211788
Substantially EquivalentNicolab B.V.
FDA 510(k) clearance K211788 for HALO, Substantially Equivalent on 2021-07-08. Applicant: Nicolab B.V.. Device class: 2.
Clearance details
- Applicant
- Nicolab B.V.
- Product code
- Code QAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.2080
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Amsterdam, NL
Recent devices under product code QAS
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