Cleared Traditional

K942486 - IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE
(FDA 510(k) Clearance)

K942486 · Mdt Corp., Inc. · General & Plastic Surgery device

Aug 1994

Decision

77d

Days

Class 1

Risk

K942486 is an FDA 510(k) clearance for the IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE. This device is classified as a Table, Operating-room, Ac-powered (Class I - General Controls, product code FQO).

Submitted by Mdt Corp., Inc. (Rochester, US). The FDA issued a Cleared decision on August 10, 1994, 77 days after receiving the submission on May 25, 1994.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number	K942486 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 25, 1994
Decision Date	August 10, 1994
Days to Decision	77 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF