STERIZONE Sterilizer— 510(k) K153689

Substantially Equivalent

Tso3, Inc.

FDA 510(k) clearance K153689 for STERIZONE Sterilizer, Substantially Equivalent on 2016-06-30. Applicant: Tso3, Inc.. Device class: 2.

Clearance details

Applicant: Tso3, Inc.
Product code: Code PJJ
Device class: Class 2
Regulation: 21 CFR 880.6860
Advisory panel: General Hospital
Date received: 2015-12-23
Decision date: 2016-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code PJJ

K190260 — STERIZONE(R) VP4 Sterilizer2019-07-19
K172191 — STERIZONE VP4 Sterilizer2018-05-09
K173694 — STERIZONE VP4 Sterilizer2018-03-13
K153392 — STERIZONE VP4 Sterilizer2016-03-24
K141163 — STERIZONE STERILIZER2014-12-17

More clearances from Tso3, Inc.

K141580 — STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR2014-12-17
K141698 — STERIZONE CHEMICAL INDICATOR2014-12-17
K090636 — TSO3 OZONE STERILIZER, MODEL 125L2009-12-02
K080198 — TSO3 OZONE STERILIZATION WRAP2008-05-30
K051595 — TSO3 OZONE STERILIZER, MODEL 125L2006-07-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.