meddevicedb.com FDA Device Reference

Electronic Sphygmomanometer (Model: LT-P30)

K220220 Class II Traditional
Decision Date
2022-10-03
Sponsor / Applicant
Zhuhai Linte Medical Instrument Co., Ltd.

Technical Specification

510(k) Submission ID K220220
Product Code DXN
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.1130
Decision Date 2022-10-03
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Electronic Sphygmomanometer (Model: LT-P30) received FDA 510(k) clearance under submission number K220220, sponsored by Zhuhai Linte Medical Instrument 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 2022-10-03.

Classification & Regulation

This clearance is catalogued under FDA product code DXN and 21 CFR 870.1130, within the Cardiovascular review panel as a Class II device.