Cleared Traditional

K904113 - OPERATIVE RECORDING CAMERA
(FDA 510(k) Clearance)

K904113 · Medical Dynamics, Inc. · Physical Medicine device
Oct 1990
Decision
54d
Days
Class 2
Risk

K904113 is an FDA 510(k) clearance for the OPERATIVE RECORDING CAMERA. This device is classified as a Hammer, Reflex, Powered (Class II - Special Controls, product code IKO).

Submitted by Medical Dynamics, Inc. (Englewood, US). The FDA issued a Cleared decision on October 30, 1990, 54 days after receiving the submission on September 6, 1990.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.1450.

Submission Details

510(k) Number K904113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1990
Decision Date October 30, 1990
Days to Decision 54 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code IKO — Hammer, Reflex, Powered
Device Class Class II - Special Controls
CFR Regulation 21 CFR 890.1450