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FDA 510(k)

PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove

K-Number: K153678 · 2016-08-08

ApplicantPermeaderm, Inc.
Decision Date2016-08-08
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove is a medical device manufactured by Permeaderm, Inc.. It received FDA 510(k) clearance on 2016-08-08 under approval number K153678. 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 PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove?

PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove is a medical device that received FDA 510(k) clearance on 2016-08-08. It is manufactured by Permeaderm, Inc.. The 510(k) number is K153678.

When was PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove approved by the FDA?

PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove received FDA 510(k) clearance on 2016-08-08, under approval number K153678.

What company makes PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove?

PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove is manufactured by Permeaderm, Inc..

What is the FDA product code for PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove?

The FDA product code for PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove 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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