HALO— 510(k) K200873
Substantially EquivalentNico-Lab B.V.
FDA 510(k) clearance K200873 for HALO, Substantially Equivalent on 2020-11-20. Applicant: Nico-Lab B.V.. Device class: 2.
Clearance details
- Applicant
- Nico-Lab 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
- Traditional
- Location
- Amsterdam, NL
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