Cleared Traditional

TENDER LIFTING CARE

K840796 · Lancer Assoc. · General Hospital
Apr 1984
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K840796 is an FDA 510(k) clearance for the TENDER LIFTING CARE, a Device, Patient Transfer, Powered (Class II — Special Controls, product code FRZ), submitted by Lancer Assoc. (Walker, US). The FDA issued a Cleared decision on April 20, 1984, 57 days after receiving the submission on February 23, 1984. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6775.

Submission Details

510(k) Number K840796 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 1984
Decision Date April 20, 1984
Days to Decision 57 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