FDA 510(k)

Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System

K-번호: K191207 · 2019-06-25

신청자Taiwan Aulisa Medical Devices Technologies, Inc.

결정일2019-06-25

제품 코드DQA

자문 위원회CV

결정Substantially Equivalent

기기 요약

Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Aulisa Medical Devices Technologies, Inc.. It received FDA 510(k) clearance on 2019-06-25 under 510(k) number K191207. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System?

Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System is a medical device that received FDA 510(k) clearance on 2019-06-25. The listed applicant is Taiwan Aulisa Medical Devices Technologies, Inc.. The 510(k) number is K191207.

When did Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System receive FDA 510(k) clearance?

Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System received FDA 510(k) clearance on 2019-06-25, under 510(k) number K191207.

Who is the listed applicant for Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System?

The FDA 510(k) record lists Taiwan Aulisa Medical Devices Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System?

The FDA product code for Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System is DQA.

Taiwan Aulisa Medical Devices Technologies, Inc.를 신청인으로 등재한 기타 기록

K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)K240220Aulisa Temperature Module (TM0002)K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System K202497Aulisa Multiple Patient Digital Vital Sign Monitoring System K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System

9개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

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