FDA 510(k)

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K-번호: K183681 · 2019-10-11

신청자Global Health Solutions (Dba Turn Therapeutics)

결정일2019-10-11

제품 코드FRO

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기기 요약

Protego Antimicrobial Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Global Health Solutions (Dba Turn Therapeutics). It received FDA 510(k) clearance on 2019-10-11 under 510(k) number K183681. 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.

자주 묻는 질문

What is the Protego Antimicrobial Wound Dressing?

Protego Antimicrobial Wound Dressing is a medical device that received FDA 510(k) clearance on 2019-10-11. The listed applicant is Global Health Solutions (Dba Turn Therapeutics). The 510(k) number is K183681.

When did Protego Antimicrobial Wound Dressing receive FDA 510(k) clearance?

Protego Antimicrobial Wound Dressing received FDA 510(k) clearance on 2019-10-11, under 510(k) number K183681.

Who is the listed applicant for Protego Antimicrobial Wound Dressing?

The FDA 510(k) record lists Global Health Solutions (Dba Turn Therapeutics) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Protego Antimicrobial Wound Dressing?

The FDA product code for Protego Antimicrobial Wound Dressing is FRO. This falls under the Anesthesiology category.

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기기 요약

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관련 임상시험

관련 기기 (코드: FRO)

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