STERIZONE STERILIZER— 510(k) K141163

Substantially Equivalent

Tso3, Inc.

FDA 510(k) clearance K141163 for STERIZONE STERILIZER, Substantially Equivalent on 2014-12-17. 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: 2014-05-05
Decision date: 2014-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, WA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Tso3, Inc.

K141580 — STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR2014-12-17
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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.