Automated external defibrillators (non-wearable)
PMA 번호: P160034 · 2020-03-01
광고
결정일2020-03-01
PMA 번호P160034
제품 코드MKJ
의료기기 등급등급 3
의학적 전문분야C
규정 번호21 CFR 8
자문 위원회CV
기기 요약
Automated external defibrillators (non-wearable) is the device name listed in this FDA 510(k) record. The listed applicant is ZOLL Medical Corporation. It received FDA 510(k) clearance on 2020-03-01. The device is classified under product code MKJ. It was reviewed by the CV advisory panel. Product code MKJ falls under the category of Dental, which includes dental instruments, materials, and equipment. Devices in this category are subject to specific FDA regulatory requirements.
자주 묻는 질문
What is the Automated external defibrillators (non-wearable)?
Automated external defibrillators (non-wearable) is a medical device that received FDA 510(k) clearance on 2020-03-01. The listed applicant is ZOLL Medical Corporation.
When did Automated external defibrillators (non-wearable) receive FDA 510(k) clearance?
The clearance date for Automated external defibrillators (non-wearable) can be found in the official FDA records.
Who is the listed applicant for Automated external defibrillators (non-wearable)?
The FDA 510(k) record lists ZOLL Medical Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Automated external defibrillators (non-wearable)?
The FDA product code for Automated external defibrillators (non-wearable) is MKJ. This falls under the Dental category.
관련 임상시험
관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.
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공식 출처
FDA 데이터베이스에서 보기 →FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.
광고