Documento fuente o registro público
FDA 510(k) K220546 — Colibrí System
FDA 510(k) index record K220546. Device: Colibrí System. Applicant as listed: Copan Wasp Srl. Decision date: 2022-10-05.
Fuente
"device_name": "Colibrí System"
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Review and references
Automated FDA record verification
2026-10-20
2026-10-30
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FDA 510(k) public index record K220546.
Device name: Colibrí System. Applicant as listed: Copan Wasp Srl.
Decision date: 2022-10-05. Decision wording: Substantially Equivalent.
Product code: LON. Regulation: 21 CFR 866.1645. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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