Cleared Traditional

K834606 - X-RAY COLLIMATOR X-CJD (FDA 510(k) Clearance)

K834606 · Knochen Dental Laboratory · Radiology device

Feb 1984

Decision

55d

Days

Class 1

Risk

K834606 is an FDA 510(k) clearance for the X-RAY COLLIMATOR X-CJD. This device is classified as a Collimator, X-ray (Class I - General Controls, product code EHB).

Submitted by Knochen Dental Laboratory (Mchenry, US). The FDA issued a Cleared decision on February 21, 1984, 55 days after receiving the submission on December 28, 1983.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1840.

Submission Details

510(k) Number	K834606 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 28, 1983
Decision Date	February 21, 1984
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	—