Cleared Traditional

POWER EXAMINATION TABLE

K882010 · Enochs Mfg., Inc. · General Hospital
Jul 1988
Decision
61d
Days
Class 1
Risk

About This 510(k) Submission

K882010 is an FDA 510(k) clearance for the POWER EXAMINATION TABLE, a Table, Examination, Medical, Powered (Class I — General Controls, product code LGX), submitted by Enochs Mfg., Inc. (Indianapolis, US). The FDA issued a Cleared decision on July 13, 1988, 61 days after receiving the submission on May 13, 1988. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number K882010 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 1988
Decision Date July 13, 1988
Days to Decision 61 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

Product Code LGX — Table, Examination, Medical, Powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4960