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FDA 510(k)

Atrauman® Ag

K-Number: K242758 · 2024-12-09

ApplicantHartmann USA, Inc.
Decision Date2024-12-09
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Atrauman® Ag is the device name listed in this FDA 510(k) record. The listed applicant is Hartmann USA, Inc.. It received FDA 510(k) clearance on 2024-12-09 under 510(k) 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. The listed applicant is Hartmann USA, Inc.. The 510(k) number is K242758.

When did Atrauman® Ag receive FDA 510(k) clearance?

Atrauman® Ag received FDA 510(k) clearance on 2024-12-09, under 510(k) number K242758.

Who is the listed applicant for Atrauman® Ag?

The FDA 510(k) record lists Hartmann USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Atrauman® Ag?

The FDA product code for Atrauman® Ag is FRO. This falls under the Anesthesiology category.

Related Devices (Code: FRO)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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