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APOLLO MULTI-RACIAL REFERENCE POPULATION

K993337 Class II Traditional
Decision Date
2000-05-16
Sponsor / Applicant
Norland Medical Systems, Inc.

Technical Specification

510(k) Submission ID K993337
Product Code KGI
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.1170
Decision Date 2000-05-16
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

APOLLO MULTI-RACIAL REFERENCE POPULATION received FDA 510(k) clearance under submission number K993337, sponsored by Norland Medical Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2000-05-16.

Classification & Regulation

This clearance is catalogued under FDA product code KGI and 21 CFR 892.1170, within the Radiology review panel as a Class II device.