Paneffort AAMI Level 3 Isolation Gown
K-Number: K212717 · 2022-11-30
ApplicantPaneffort, LLC
Decision Date2022-11-30
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Paneffort AAMI Level 3 Isolation Gown is a medical device manufactured by Paneffort, LLC. It received FDA 510(k) clearance on 2022-11-30 under approval number K212717. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Paneffort AAMI Level 3 Isolation Gown?
Paneffort AAMI Level 3 Isolation Gown is a medical device that received FDA 510(k) clearance on 2022-11-30. It is manufactured by Paneffort, LLC. The 510(k) number is K212717.
When was Paneffort AAMI Level 3 Isolation Gown approved by the FDA?
Paneffort AAMI Level 3 Isolation Gown received FDA 510(k) clearance on 2022-11-30, under approval number K212717.
What company makes Paneffort AAMI Level 3 Isolation Gown?
Paneffort AAMI Level 3 Isolation Gown is manufactured by Paneffort, LLC.
What is the FDA product code for Paneffort AAMI Level 3 Isolation Gown?
The FDA product code for Paneffort AAMI Level 3 Isolation Gown is FYC.
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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.