Decision Date2022-03-18
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
CELERITY 20 HP Challenge Pack is a medical device manufactured by Steris. It received FDA 510(k) clearance on 2022-03-18 under approval number K220473. 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 CELERITY 20 HP Challenge Pack?
CELERITY 20 HP Challenge Pack is a medical device that received FDA 510(k) clearance on 2022-03-18. It is manufactured by Steris. The 510(k) number is K220473.
When was CELERITY 20 HP Challenge Pack approved by the FDA?
CELERITY 20 HP Challenge Pack received FDA 510(k) clearance on 2022-03-18, under approval number K220473.
What company makes CELERITY 20 HP Challenge Pack?
CELERITY 20 HP Challenge Pack is manufactured by Steris.
What is the FDA product code for CELERITY 20 HP Challenge Pack?
The FDA product code for CELERITY 20 HP Challenge 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.