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FDA 510(k)

STERIZONE Sterilizer

K-Number: K153689 · 2016-06-30

ApplicantTso3, Inc.
Decision Date2016-06-30
Product CodePJJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERIZONE Sterilizer is a medical device manufactured by Tso3, Inc.. It received FDA 510(k) clearance on 2016-06-30 under approval number K153689. The device is classified under product code PJJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERIZONE Sterilizer?

STERIZONE Sterilizer is a medical device that received FDA 510(k) clearance on 2016-06-30. It is manufactured by Tso3, Inc.. The 510(k) number is K153689.

When was STERIZONE Sterilizer approved by the FDA?

STERIZONE Sterilizer received FDA 510(k) clearance on 2016-06-30, under approval number K153689.

What company makes STERIZONE Sterilizer?

STERIZONE Sterilizer is manufactured by Tso3, Inc..

What is the FDA product code for STERIZONE Sterilizer?

The FDA product code for STERIZONE Sterilizer is PJJ.

Other Devices by Tso3, Inc.

K172191STERIZONE VP4 Sterilizer K173694STERIZONE VP4 Sterilizer K190260STERIZONE(R) VP4 Sterilizer

Related Devices (Code: PJJ)

K153392STERIZONE VP4 SterilizerTs03, Inc. K172191STERIZONE VP4 SterilizerTso3, Inc. K173694STERIZONE VP4 SterilizerTso3, Inc. K190260STERIZONE(R) VP4 SterilizerTso3, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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