Atrauman® Ag
K-Number: K242758 · 2024-12-09
ApplicantHartmann USA, Inc.
Decision Date2024-12-09
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
Atrauman® Ag is a medical device manufactured by Hartmann USA, Inc.. It received FDA 510(k) clearance on 2024-12-09 under approval number K242758. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Atrauman® Ag?
Atrauman® Ag is a medical device that received FDA 510(k) clearance on 2024-12-09. It is manufactured by Hartmann USA, Inc.. The 510(k) number is K242758.
When was Atrauman® Ag approved by the FDA?
Atrauman® Ag received FDA 510(k) clearance on 2024-12-09, under approval number K242758.
What company makes Atrauman® Ag?
Atrauman® Ag is manufactured by Hartmann USA, Inc..
What is the FDA product code for Atrauman® Ag?
The FDA product code for Atrauman® Ag is FRO. This falls under the Anesthesiology category.
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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.