Cleared Traditional

ADULT-PEDIATRIC TRANSPORT SYSTEM

K955766 · International Biomedical, Inc. · General Hospital
Aug 1996
Decision
231d
Days
Class 2
Risk

About This 510(k) Submission

K955766 is an FDA 510(k) clearance for the ADULT-PEDIATRIC TRANSPORT SYSTEM, a Stretcher, Wheeled (Class II — Special Controls, product code FPO), submitted by International Biomedical, Inc. (Austin, US). The FDA issued a Cleared decision on August 7, 1996, 231 days after receiving the submission on December 20, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6910.

Submission Details

510(k) Number K955766 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 1995
Decision Date August 07, 1996
Days to Decision 231 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FPO — Stretcher, Wheeled
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6910