STERIZONE VP4 Test Pack
K-Number: K203560 · 2021-03-24
ApplicantTso3 Inc., Now A Part of Stryker
Decision Date2021-03-24
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
STERIZONE VP4 Test Pack is a medical device manufactured by Tso3 Inc., Now A Part of Stryker. It received FDA 510(k) clearance on 2021-03-24 under approval number K203560. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the STERIZONE VP4 Test Pack?
STERIZONE VP4 Test Pack is a medical device that received FDA 510(k) clearance on 2021-03-24. It is manufactured by Tso3 Inc., Now A Part of Stryker. The 510(k) number is K203560.
When was STERIZONE VP4 Test Pack approved by the FDA?
STERIZONE VP4 Test Pack received FDA 510(k) clearance on 2021-03-24, under approval number K203560.
What company makes STERIZONE VP4 Test Pack?
STERIZONE VP4 Test Pack is manufactured by Tso3 Inc., Now A Part of Stryker.
What is the FDA product code for STERIZONE VP4 Test Pack?
The FDA product code for STERIZONE VP4 Test Pack is FRC.
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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.