Cleared Traditional

K843134 - MOBILE OPERATING TABLE HEIDELBERGS 1130
(FDA 510(k) Clearance)

Sep 1984
Decision
29d
Days
Class 1
Risk

K843134 is an FDA 510(k) clearance for the MOBILE OPERATING TABLE HEIDELBERGS 1130. This device is classified as a Table, Operating-room, Electrical (Class I - General Controls, product code GDC).

Submitted by Stierlen-Maquet AG (Mchenry, US). The FDA issued a Cleared decision on September 7, 1984, 29 days after receiving the submission on August 9, 1984.

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

Submission Details

510(k) Number K843134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1984
Decision Date September 07, 1984
Days to Decision 29 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code GDC — Table, Operating-room, Electrical
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4960

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