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FDA 510(k)

TSO3 OZONE STERILIZER, MODEL 125L

K-Number: K090636 · 2009-12-02

ApplicantTso3, Inc.
Decision Date2009-12-02
Product CodeFLF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TSO3 OZONE STERILIZER, MODEL 125L is the device name listed in this FDA 510(k) record. The listed applicant is Tso3, Inc.. It received FDA 510(k) clearance on 2009-12-02 under 510(k) number K090636. The device is classified under product code FLF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TSO3 OZONE STERILIZER, MODEL 125L?

TSO3 OZONE STERILIZER, MODEL 125L is a medical device that received FDA 510(k) clearance on 2009-12-02. The listed applicant is Tso3, Inc.. The 510(k) number is K090636.

When did TSO3 OZONE STERILIZER, MODEL 125L receive FDA 510(k) clearance?

TSO3 OZONE STERILIZER, MODEL 125L received FDA 510(k) clearance on 2009-12-02, under 510(k) number K090636.

Who is the listed applicant for TSO3 OZONE STERILIZER, MODEL 125L?

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 TSO3 OZONE STERILIZER, MODEL 125L?

The FDA product code for TSO3 OZONE STERILIZER, MODEL 125L is FLF.

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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 SterilizerK172191STERIZONE VP4 SterilizerK173694STERIZONE VP4 SterilizerK153689STERIZONE SterilizerK080198TSO3 OZONE STERILIZATION WRAPK051595TSO3 OZONE STERILIZER, MODEL 125L

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Related Devices (Code: FLF)

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.

K192978EOGas 4 Ethylene Oxide Gas SterilizerAndersen Sterilizers, Inc.K170432Anprolene AN75 Ethylene Oxide Gas SterilizerAndersen Sterilizers, Inc.K051595TSO3 OZONE STERILIZER, MODEL 125LTso3, Inc.K020875TSO3 OZONE STERILIZER, MODEL 125LTechnologies of Sterilization With Oxone, Tso3, Inc.K014013H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEMH & W Technology, LLCK023290STERRAD 50 & STERRAD 100S STERILIZERSAdvanced Sterilization Products

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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