Cleared Traditional

K892659 - ELECTRODELCA
(FDA 510(k) Clearance)

K892659 · Oldelft Corp. of America · Radiology

Nov 1989

Decision

222d

Days

Class 2

Risk

K892659 is an FDA 510(k) clearance for the ELECTRODELCA. This device is classified as a System, X-ray, Photofluorographic (Class II — Special Controls, product code IZG).

Submitted by Oldelft Corp. of America (Fairfax, US). The FDA issued a Cleared decision on November 21, 1989, 222 days after receiving the submission on April 13, 1989.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1730.

Submission Details

510(k) Number	K892659 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 13, 1989
Decision Date	November 21, 1989
Days to Decision	222 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	—