Biatain Silicone Ag
K-Number: K191536 · 2020-02-21
Device Summary
Biatain Silicone Ag is a medical device manufactured by Coloplast A/S. It received FDA 510(k) clearance on 2020-02-21 under approval number K191536. 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 Biatain Silicone Ag?
Biatain Silicone Ag is a medical device that received FDA 510(k) clearance on 2020-02-21. It is manufactured by Coloplast A/S. The 510(k) number is K191536.
When was Biatain Silicone Ag approved by the FDA?
Biatain Silicone Ag received FDA 510(k) clearance on 2020-02-21, under approval number K191536.
What company makes Biatain Silicone Ag?
Biatain Silicone Ag is manufactured by Coloplast A/S.
What is the FDA product code for Biatain Silicone Ag?
The FDA product code for Biatain Silicone Ag 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.