FDA 510(k)

프로펠러 센서 for Symbicort

K-번호: K192724 · 2020-03-26

결정일2020-03-26

제품 코드CAF

자문 위원회안내: 의료기기 규제 문서 번역 요청입니다. 회사명, 제품명, FDA, 510(k), PMA, NCT, PMID, 식별자 및 URL을 보존하여 번역하여 주세요. 정책: 의료규제-v1. [원문] AN [번역] 안내

결정Substantially Equivalent

기기 요약

Propeller Sensor for Symbicort is the device name listed in this FDA 510(k) record. The listed applicant is Reciprocal Labs Corporation. It received FDA 510(k) clearance on 2020-03-26 under 510(k) number K192724. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Propeller Sensor for Symbicort?

Propeller Sensor for Symbicort is a medical device that received FDA 510(k) clearance on 2020-03-26. The listed applicant is Reciprocal Labs Corporation. The 510(k) number is K192724.

When did Propeller Sensor for Symbicort receive FDA 510(k) clearance?

Propeller Sensor for Symbicort received FDA 510(k) clearance on 2020-03-26, under 510(k) number K192724.

Who is the listed applicant for Propeller Sensor for Symbicort?

The FDA 510(k) record lists Reciprocal Labs Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Propeller Sensor for Symbicort?

The FDA product code for Propeller Sensor for Symbicort is CAF.

Reciprocal Labs Corporation를 신청인으로 등재한 기타 기록

K180770네오할러를 위한 프로펠러 센서 K161454프로펠러 센서 모델 2015-E

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