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MEDIQUIP I.A. FIELD CONV KIT/AMSCO 2080 SER TABLE

K914417 Class II Traditional
Decision Date
1992-02-27
Sponsor / Applicant
Med-Vac, Inc.

Technical Specification

510(k) Submission ID K914417
Product Code IXR
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.1980
Decision Date 1992-02-27
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

MEDIQUIP I.A. FIELD CONV KIT/AMSCO 2080 SER TABLE received FDA 510(k) clearance under submission number K914417, sponsored by Med-Vac, 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 1992-02-27.

Classification & Regulation

This clearance is catalogued under FDA product code IXR and 21 CFR 892.1980, within the Radiology review panel as a Class II device.