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FDA 510(k)

HYPO CLENZ WOUND WASH MODEL 100 PPM

K-Number: K100948 · 2011-02-02

ApplicantNevoa Life Sciences, LLC
Decision Date2011-02-02
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

HYPO CLENZ WOUND WASH MODEL 100 PPM is the device name listed in this FDA 510(k) record. The listed applicant is Nevoa Life Sciences, LLC. It received FDA 510(k) clearance on 2011-02-02 under 510(k) number K100948. 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 HYPO CLENZ WOUND WASH MODEL 100 PPM?

HYPO CLENZ WOUND WASH MODEL 100 PPM is a medical device that received FDA 510(k) clearance on 2011-02-02. The listed applicant is Nevoa Life Sciences, LLC. The 510(k) number is K100948.

When did HYPO CLENZ WOUND WASH MODEL 100 PPM receive FDA 510(k) clearance?

HYPO CLENZ WOUND WASH MODEL 100 PPM received FDA 510(k) clearance on 2011-02-02, under 510(k) number K100948.

Who is the listed applicant for HYPO CLENZ WOUND WASH MODEL 100 PPM?

The FDA 510(k) record lists Nevoa Life Sciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYPO CLENZ WOUND WASH MODEL 100 PPM?

The FDA product code for HYPO CLENZ WOUND WASH MODEL 100 PPM is FRO. This falls under the Anesthesiology category.

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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

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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