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FDA 510(k)

L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE

K-Number: K053613 · 2007-07-25

ApplicantTheo Manufacturing BV
Decision Date2007-07-25
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE is the device name listed in this FDA 510(k) record. The listed applicant is Theo Manufacturing BV. It received FDA 510(k) clearance on 2007-07-25 under 510(k) number K053613. 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 L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE?

L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE is a medical device that received FDA 510(k) clearance on 2007-07-25. The listed applicant is Theo Manufacturing BV. The 510(k) number is K053613.

When did L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE receive FDA 510(k) clearance?

L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE received FDA 510(k) clearance on 2007-07-25, under 510(k) number K053613.

Who is the listed applicant for L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE?

The FDA 510(k) record lists Theo Manufacturing BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE?

The FDA product code for L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE 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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