Cleared Traditional

K911120 - DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21
(FDA 510(k) Clearance)

K911120 · Hamo USA, Inc. · General Hospital
Feb 1994
Decision
1060d
Days
Class 2
Risk

K911120 is an FDA 510(k) clearance for the DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21. This device is classified as a Disinfector, Medical Devices (Class II — Special Controls, product code MEC).

Submitted by Hamo USA, Inc. (Miami, US). The FDA issued a Cleared decision on February 3, 1994, 1060 days after receiving the submission on March 11, 1991.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6992.

Submission Details

510(k) Number K911120 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 1991
Decision Date February 03, 1994
Days to Decision 1060 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code MEC — Disinfector, Medical Devices
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6992