Parathyroid Detection (Model PTeye) System

Parathyroid Autofluorescence Detection Device

AiBiomed, Corp.

The following data is part of a De Novo classification by Aibiomed, Corp. with the FDA for Parathyroid Detection (model Pteye) System.

Pre-market Notification Details

DeNovo IDDEN170056
Device Name:Parathyroid Detection (Model PTeye) System
ClassificationParathyroid Autofluorescence Detection Device
Applicant AiBiomed, Corp. 107 West Gutierrez Sreet Santa Barbara,  CA  93101
ContactAl Memmolo
Product CodeQDF  
CFR Regulation Number878.4550 [🔎]
DecisionGranted (DENG)
501(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardGeneral & Plastic Surgery
Classification AdvisoryGeneral & Plastic Surgery
TypeDirect
Date Received2017-09-25
Decision Date2018-11-02
Reclassification Order:Reclassification Order

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