Neonatal Phototherapy System— 510(k) K200031

Substantially Equivalent

Avalon Biomedical (Shenzhen) Limited

FDA 510(k) clearance K200031 for Neonatal Phototherapy System, Substantially Equivalent on 2020-10-05. Applicant: Avalon Biomedical (Shenzhen) Limited.

Clearance details

Applicant: Avalon Biomedical (Shenzhen) Limited
Product code: Code LBI
Advisory panel: General Hospital
Date received: 2020-01-07
Decision date: 2020-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longhua District, CN

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