FDA 510(k)

STERIZONE Sterilizer

K-Number: K153689 · 2016-06-30

Decision Date2016-06-30

Product CodePJJ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STERIZONE Sterilizer is the device name listed in this FDA 510(k) record. The listed applicant is Tso3, Inc.. It received FDA 510(k) clearance on 2016-06-30 under 510(k) 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. The listed applicant is Tso3, Inc.. The 510(k) number is K153689.

When did STERIZONE Sterilizer receive FDA 510(k) clearance?

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

Who is the listed applicant for STERIZONE Sterilizer?

The FDA 510(k) record lists Tso3, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERIZONE Sterilizer?

The FDA product code for STERIZONE Sterilizer is PJJ.

Other records listing Tso3, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: PJJ)

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

Official Source

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