Cleared Traditional

BABY POD

K030283 · Prism Enterprises, Inc. · General Hospital
Apr 2003
Decision
85d
Days
Class 1
Risk

About This 510(k) Submission

K030283 is an FDA 510(k) clearance for the BABY POD, a Stretcher, Hand-carried (Class I — General Controls, product code FPP), submitted by Prism Enterprises, Inc. (Stillwater, US). The FDA issued a Cleared decision on April 22, 2003, 85 days after receiving the submission on January 27, 2003. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6900.

Submission Details

510(k) Number K030283 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2003
Decision Date April 22, 2003
Days to Decision 85 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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