FDA 510(k)

npSIMS 음압 수술 절개 관리 시스템™ (npSIMS)™

K-번호: K201400 · 2021-08-23

결정일2021-08-23

제품 코드QPX

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

결정대체적으로 동일

기기 요약

npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™ is the device name listed in this FDA 510(k) record. The listed applicant is Aatru Medical, LLC. It received FDA 510(k) clearance on 2021-08-23 under 510(k) number K201400. The device is classified under product code QPX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™?

npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™ is a medical device that received FDA 510(k) clearance on 2021-08-23. The listed applicant is Aatru Medical, LLC. The 510(k) number is K201400.

When did npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™ receive FDA 510(k) clearance?

npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™ received FDA 510(k) clearance on 2021-08-23, under 510(k) number K201400.

Who is the listed applicant for npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™?

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

What is the FDA product code for npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™?

The FDA product code for npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™ is QPX.

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

기기 요약

자주 묻는 질문

관련 임상시험

공식 출처