Cleared Traditional

DONWAY LIFTING FRAME

K851660 · Australian Biomedical Corporation , Ltd. · General Hospital
Aug 1985
Decision
106d
Days
Class 1
Risk

About This 510(k) Submission

K851660 is an FDA 510(k) clearance for the DONWAY LIFTING FRAME, a Stretcher, Hand-carried (Class I — General Controls, product code FPP), submitted by Australian Biomedical Corporation , Ltd. (Australia, AU). The FDA issued a Cleared decision on August 7, 1985, 106 days after receiving the submission on April 23, 1985. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6900.

Submission Details

510(k) Number K851660 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 1985
Decision Date August 07, 1985
Days to Decision 106 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FPP — Stretcher, Hand-carried
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6900