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FDA 510(k)

PROTHELIAL

K-Number: K123904 · 2013-08-07

ApplicantMueller Medical International, LLC
Decision Date2013-08-07
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

PROTHELIAL is the device name listed in this FDA 510(k) record. The listed applicant is Mueller Medical International, LLC. It received FDA 510(k) clearance on 2013-08-07 under 510(k) number K123904. 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 PROTHELIAL?

PROTHELIAL is a medical device that received FDA 510(k) clearance on 2013-08-07. The listed applicant is Mueller Medical International, LLC. The 510(k) number is K123904.

When did PROTHELIAL receive FDA 510(k) clearance?

PROTHELIAL received FDA 510(k) clearance on 2013-08-07, under 510(k) number K123904.

Who is the listed applicant for PROTHELIAL?

The FDA 510(k) record lists Mueller Medical International, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROTHELIAL?

The FDA product code for PROTHELIAL is FRO. This falls under the Anesthesiology category.

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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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