Cleared Traditional

LCI MEDICAL INC AIR/PAL

K841728 · Lehigh Consolidated Industries · General Hospital
Jun 1984
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K841728 is an FDA 510(k) clearance for the LCI MEDICAL INC AIR/PAL, a Device, Patient Transfer, Powered (Class II — Special Controls, product code FRZ), submitted by Lehigh Consolidated Industries (Mchenry, US). The FDA issued a Cleared decision on June 5, 1984, 41 days after receiving the submission on April 25, 1984. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6775.

Submission Details

510(k) Number K841728 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 1984
Decision Date June 05, 1984
Days to Decision 41 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FRZ — Device, Patient Transfer, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6775