Cleared Traditional

K090636 - TSO3 OZONE STERILIZER, MODEL 125L
(FDA 510(k) Clearance)

K090636 · Tso3, Inc. · General Hospital

Dec 2009

Decision

267d

Days

Class 2

Risk

K090636 is an FDA 510(k) clearance for the TSO3 OZONE STERILIZER, MODEL 125L. This device is classified as a Sterilizer, Ethylene-oxide Gas (Class II — Special Controls, product code FLF).

Submitted by Tso3, Inc. (Fairport, US). The FDA issued a Cleared decision on December 2, 2009, 267 days after receiving the submission on March 10, 2009.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6860.

Submission Details

510(k) Number	K090636 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 10, 2009
Decision Date	December 02, 2009
Days to Decision	267 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF