FDA 510(k)

PWD 음압 치료 장비 시스템

K-번호: K212359 · 2022-09-21

결정일2022-09-21

제품 코드OMP

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

PWD Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Applied Tissue Technologies, LLC. It received FDA 510(k) clearance on 2022-09-21 under 510(k) number K212359. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the PWD Negative Pressure Wound Therapy System?

PWD Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2022-09-21. The listed applicant is Applied Tissue Technologies, LLC. The 510(k) number is K212359.

When did PWD Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

PWD Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2022-09-21, under 510(k) number K212359.

Who is the listed applicant for PWD Negative Pressure Wound Therapy System?

The FDA 510(k) record lists Applied Tissue Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PWD Negative Pressure Wound Therapy System?

The FDA product code for PWD Negative Pressure Wound Therapy System is OMP.

Applied Tissue Technologies, LLC를 신청인으로 등재한 기타 기록

K191460PWD 플랫폼 상처 치료 패치 3” x 5” 연장형 K182409Applied Tissue Technologies PWD™ Platform Wound Dressing

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