Cleared Traditional

MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM

K942233 · Carl Zeiss, Inc. · General & Plastic Surgery
Jul 1994
Decision
53d
Days
Class 1
Risk

About This 510(k) Submission

K942233 is an FDA 510(k) clearance for the MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM, a Microscope, Surgical (Class I — General Controls, product code EPT), submitted by Carl Zeiss, Inc. (Thornwood, US). The FDA issued a Cleared decision on July 1, 1994, 53 days after receiving the submission on May 9, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4700.

Submission Details

510(k) Number K942233 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 1994
Decision Date July 01, 1994
Days to Decision 53 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code EPT — Microscope, Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4700

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