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VISCOPE, MODEL 100P,100S

K100531 Class II Traditional
Decision Date
2010-07-21
Sponsor / Applicant
Hd Medical Services (India) Pvt.Ltd

Technical Specification

510(k) Submission ID K100531
Product Code DQD
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.1875
Decision Date 2010-07-21
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

VISCOPE, MODEL 100P,100S received FDA 510(k) clearance under submission number K100531, sponsored by Hd Medical Services (India) Pvt.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 2010-07-21.

Classification & Regulation

This clearance is catalogued under FDA product code DQD and 21 CFR 870.1875, within the Cardiovascular review panel as a Class II device.