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FDA 510(k)

TSO3 OZONE CHEMICAL INDICATOR

K-Number: K021161 · 2003-08-27

ApplicantTechnologies of Sterilization With Oxone, Tso3, Inc.
Decision Date2003-08-27
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TSO3 OZONE CHEMICAL INDICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Technologies of Sterilization With Oxone, Tso3, Inc.. It received FDA 510(k) clearance on 2003-08-27 under 510(k) number K021161. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TSO3 OZONE CHEMICAL INDICATOR?

TSO3 OZONE CHEMICAL INDICATOR is a medical device that received FDA 510(k) clearance on 2003-08-27. The listed applicant is Technologies of Sterilization With Oxone, Tso3, Inc.. The 510(k) number is K021161.

When did TSO3 OZONE CHEMICAL INDICATOR receive FDA 510(k) clearance?

TSO3 OZONE CHEMICAL INDICATOR received FDA 510(k) clearance on 2003-08-27, under 510(k) number K021161.

Who is the listed applicant for TSO3 OZONE CHEMICAL INDICATOR?

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

What is the FDA product code for TSO3 OZONE CHEMICAL INDICATOR?

The FDA product code for TSO3 OZONE CHEMICAL INDICATOR is JOJ.

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Other records listing Technologies of Sterilization With Oxone, 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.

K020875TSO3 OZONE STERILIZER, MODEL 125L

Related Devices (Code: JOJ)

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.

K2619923M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)Solventum US, LLCK260181LF Process Indicator Tape for Steam SterilizationIntertape Polymer GroupK251991SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.K251035DISINTEK™ PA Test StripsSerim ResearchK251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS CorporationK243876VERIFY STEAM Integrating IndicatorSTERIS Corporation

Official Source

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