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SUMMED INFLATION DEVICE KIT

K133795 Class II Traditional
Decision Date
2014-12-12
Sponsor / Applicant
Sunny Medical Device (Shenzhen) Co., Ltd.

Technical Specification

510(k) Submission ID K133795
Product Code MAV
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.1650
Decision Date 2014-12-12
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

SUMMED INFLATION DEVICE KIT received FDA 510(k) clearance under submission number K133795, sponsored by Sunny Medical Device (Shenzhen) 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 2014-12-12.

Classification & Regulation

This clearance is catalogued under FDA product code MAV and 21 CFR 870.1650, within the Cardiovascular review panel as a Class II device.