meddevicedb.com FDA Device Reference

ANEROID TYPE BLOOD PRESSURE KIT

K780715 Class II Traditional
Decision Date
1978-07-17
Sponsor / Applicant
Mars Metal Co., Ltd.

Technical Specification

510(k) Submission ID K780715
Product Code DXQ
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.1120
Decision Date 1978-07-17
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

ANEROID TYPE BLOOD PRESSURE KIT received FDA 510(k) clearance under submission number K780715, sponsored by Mars Metal 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 1978-07-17.

Classification & Regulation

This clearance is catalogued under FDA product code DXQ and 21 CFR 870.1120, within the Cardiovascular review panel as a Class II device.