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FDA 510(k)

HaloGUARD Protective Disc with CHG

K-Number: K200641 · 2020-09-03

ApplicantAttwill Medical Solutions
Decision Date2020-09-03
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

HaloGUARD Protective Disc with CHG is a medical device manufactured by Attwill Medical Solutions. It received FDA 510(k) clearance on 2020-09-03 under approval number K200641. 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 HaloGUARD Protective Disc with CHG?

HaloGUARD Protective Disc with CHG is a medical device that received FDA 510(k) clearance on 2020-09-03. It is manufactured by Attwill Medical Solutions. The 510(k) number is K200641.

When was HaloGUARD Protective Disc with CHG approved by the FDA?

HaloGUARD Protective Disc with CHG received FDA 510(k) clearance on 2020-09-03, under approval number K200641.

What company makes HaloGUARD Protective Disc with CHG?

HaloGUARD Protective Disc with CHG is manufactured by Attwill Medical Solutions.

What is the FDA product code for HaloGUARD Protective Disc with CHG?

The FDA product code for HaloGUARD Protective Disc with CHG 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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