FDA 510(k)

STERIZONE VP4 Sterilizer

K-Number: K153392 · 2016-03-24

Decision Date2016-03-24

Product CodePJJ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STERIZONE VP4 Sterilizer is the device name listed in this FDA 510(k) record. The listed applicant is Ts03, Inc.. It received FDA 510(k) clearance on 2016-03-24 under 510(k) number K153392. 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 VP4 Sterilizer?

STERIZONE VP4 Sterilizer is a medical device that received FDA 510(k) clearance on 2016-03-24. The listed applicant is Ts03, Inc.. The 510(k) number is K153392.

When did STERIZONE VP4 Sterilizer receive FDA 510(k) clearance?

STERIZONE VP4 Sterilizer received FDA 510(k) clearance on 2016-03-24, under 510(k) number K153392.

Who is the listed applicant for STERIZONE VP4 Sterilizer?

The FDA 510(k) record lists Ts03, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERIZONE VP4 Sterilizer?

The FDA product code for STERIZONE VP4 Sterilizer is PJJ.

Related Devices (Code: PJJ)

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 SterilizerTso3, Inc.K172191STERIZONE VP4 SterilizerTso3, Inc.K173694STERIZONE VP4 SterilizerTso3, Inc.K153689STERIZONE SterilizerTso3, 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.