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Venen-trainer (Model: FM150, SFM90)

K203746 Class II Traditional
Decision Date
2021-11-10
Sponsor / Applicant
Shenzhen Pango Electronic Co., Ltd.

Technical Specification

510(k) Submission ID K203746
Product Code JOW
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.5800
Decision Date 2021-11-10
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Venen-trainer (Model: FM150, SFM90) received FDA 510(k) clearance under submission number K203746, sponsored by Shenzhen Pango Electronic Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2021-11-10.

Classification & Regulation

This clearance is catalogued under FDA product code JOW and 21 CFR 870.5800, within the Cardiovascular review panel as a Class II device.