Cleared Traditional

K843192 - APR MOBILE (FDA 510(k) Clearance)

K843192 · Philips Medical Systems (Cleveland), Inc. · Radiology device

Sep 1984

Decision

22d

Days

Class 2

Risk

K843192 is an FDA 510(k) clearance for the APR MOBILE. This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).

Submitted by Philips Medical Systems (Cleveland), Inc. (Mchenry, US). The FDA issued a Cleared decision on September 5, 1984, 22 days after receiving the submission on August 14, 1984.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number	K843192 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 14, 1984
Decision Date	September 05, 1984
Days to Decision	22 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	—