Cleared Traditional

K911564 - E-Z LIFT IMAGING TABLE WITH FOOT PUMP
(FDA 510(k) Clearance)

K911564 · Med-Tron Products, Inc. · Radiology device

Jul 1991

Decision

97d

Days

Class 1

Risk

K911564 is an FDA 510(k) clearance for the E-Z LIFT IMAGING TABLE WITH FOOT PUMP. This device is classified as a Bed, Scanning, Nuclear (Class I - General Controls, product code IYZ).

Submitted by Med-Tron Products, Inc. (Miller Place, US). The FDA issued a Cleared decision on July 15, 1991, 97 days after receiving the submission on April 9, 1991.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1350.

Submission Details

510(k) Number	K911564 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 09, 1991
Decision Date	July 15, 1991
Days to Decision	97 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	—