Cleared Traditional

K860904 - VIDEO PRINTER, MODEL 3200 (FDA 510(k) Clearance)

Mar 1986
Decision
18d
Days
Class 1
Risk

K860904 is an FDA 510(k) clearance for the VIDEO PRINTER, MODEL 3200. This device is classified as a Camera, Surgical And Accessories (Class I - General Controls, product code KQM).

Submitted by Medline Industries, Inc. (Englewood, US). The FDA issued a Cleared decision on March 28, 1986, 18 days after receiving the submission on March 10, 1986.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4160.

Submission Details

510(k) Number K860904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1986
Decision Date March 28, 1986
Days to Decision 18 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code KQM — Camera, Surgical And Accessories
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4160