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FDA 510(k)

REVERA WOUND CARE, MODEL MDW0060

K-Number: K070463 · 2008-05-07

ApplicantRevalesio Corporation
Decision Date2008-05-07
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

REVERA WOUND CARE, MODEL MDW0060 is the device name listed in this FDA 510(k) record. The listed applicant is Revalesio Corporation. It received FDA 510(k) clearance on 2008-05-07 under 510(k) number K070463. 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 REVERA WOUND CARE, MODEL MDW0060?

REVERA WOUND CARE, MODEL MDW0060 is a medical device that received FDA 510(k) clearance on 2008-05-07. The listed applicant is Revalesio Corporation. The 510(k) number is K070463.

When did REVERA WOUND CARE, MODEL MDW0060 receive FDA 510(k) clearance?

REVERA WOUND CARE, MODEL MDW0060 received FDA 510(k) clearance on 2008-05-07, under 510(k) number K070463.

Who is the listed applicant for REVERA WOUND CARE, MODEL MDW0060?

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

What is the FDA product code for REVERA WOUND CARE, MODEL MDW0060?

The FDA product code for REVERA WOUND CARE, MODEL MDW0060 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.

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