Cleared Traditional

K051595 - TSO3 OZONE STERILIZER, MODEL 125L
(FDA 510(k) Clearance)

K051595 · Tso3, Inc. · General Hospital

Jul 2006

Decision

405d

Days

Class 2

Risk

K051595 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 July 26, 2006, 405 days after receiving the submission on June 16, 2005.

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

Submission Details

510(k) Number	K051595 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 16, 2005
Decision Date	July 26, 2006
Days to Decision	405 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF