Cleared Traditional

K920704 - STRYKER I.V. CADDY ACCESSORY DEVICE (FDA 510(k) Clearance)

Mar 1992
Decision
34d
Days
Class 2
Risk

K920704 is an FDA 510(k) clearance for the STRYKER I.V. CADDY ACCESSORY DEVICE. This device is classified as a Stretcher, Wheeled (Class II - Special Controls, product code FPO).

Submitted by Stryker Medical (Kalamazoo, US). The FDA issued a Cleared decision on March 23, 1992, 34 days after receiving the submission on February 18, 1992.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6910.

Submission Details

510(k) Number K920704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1992
Decision Date March 23, 1992
Days to Decision 34 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