meddevicedb.com FDA Device Reference

Parathyroid Detection (Model PTeye) System

DEN170056 Class II Direct
Decision Date
2018-11-02
Sponsor / Applicant
Aibiomed, Corp.

Technical Specification

510(k) Submission ID DEN170056
Product Code QDF
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4550
Decision Date 2018-11-02
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Parathyroid Detection (Model PTeye) System received FDA 510(k) clearance under submission number DEN170056, sponsored by Aibiomed, Corp.. The device was reviewed via the Direct premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2018-11-02.

Classification & Regulation

This clearance is catalogued under FDA product code QDF and 21 CFR 878.4550, within the General, Plastic Surgery review panel as a Class II device.