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LITEPAC, MODEL 682

K100490 Class II Special
Decision Date
2010-03-16
Sponsor / Applicant
ClearStream Technologies , Ltd.

Technical Specification

510(k) Submission ID K100490
Product Code LIT
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.1250
Decision Date 2010-03-16
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

LITEPAC, MODEL 682 received FDA 510(k) clearance under submission number K100490, sponsored by ClearStream Technologies , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2010-03-16.

Classification & Regulation

This clearance is catalogued under FDA product code LIT and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.