Cleared Traditional

K904511 - HAND-CARRIED STRETCHERS/BREAK AWAY FLAT
(FDA 510(k) Clearance)

Oct 1990
Decision
10d
Days
Class 1
Risk

K904511 is an FDA 510(k) clearance for the HAND-CARRIED STRETCHERS/BREAK AWAY FLAT. This device is classified as a Stretcher, Hand-carried (Class I - General Controls, product code FPP).

Submitted by Minto Research & Development, Inc. (Redding, US). The FDA issued a Cleared decision on October 12, 1990, 10 days after receiving the submission on October 2, 1990.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6900.

Submission Details

510(k) Number K904511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1990
Decision Date October 12, 1990
Days to Decision 10 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