FDA 510(k)

eRapid with eTrack System

K-번호: K251572 · 2025-12-19

결정일2025-12-19

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

eRapid with eTrack System is the device name listed in this FDA 510(k) record. The listed applicant is Pari Respiratory Equipment, Inc.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K251572. 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 eRapid with eTrack System?

eRapid with eTrack System is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Pari Respiratory Equipment, Inc.. The 510(k) number is K251572.

When did eRapid with eTrack System receive FDA 510(k) clearance?

eRapid with eTrack System received FDA 510(k) clearance on 2025-12-19, under 510(k) number K251572.

Who is the listed applicant for eRapid with eTrack System?

The FDA 510(k) record lists Pari Respiratory Equipment, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for eRapid with eTrack System?

The FDA product code for eRapid with eTrack System is CAF.

Pari Respiratory Equipment, Inc.를 신청인으로 등재한 기타 기록

K223840eRapid Nebulizer System K191270Proneb Max K162785Velox Nebulizer System K150044O-PEP

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