Cleared Traditional

K873478 - SKYTRON MODEL 130 SURGICAL TABLE
(FDA 510(k) Clearance)

Sep 1987
Decision
31d
Days
Class 1
Risk

K873478 is an FDA 510(k) clearance for the SKYTRON MODEL 130 SURGICAL TABLE. This device is classified as a Table, Operating-room, Non-electrical (Class I - General Controls, product code FWY).

Submitted by Skytron, Div. the Kmw Group, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on September 24, 1987, 31 days after receiving the submission on August 24, 1987.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4950.

Submission Details

510(k) Number K873478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1987
Decision Date September 24, 1987
Days to Decision 31 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code FWY — Table, Operating-room, Non-electrical
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4950