FDA 510(k)

EasyCare Tx 2

K-번호: K241939 · 2024-09-27

결정일2024-09-27

제품 코드BZD

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

EasyCare Tx 2 is the device name listed in this FDA 510(k) record. The listed applicant is Resmed Corp. It received FDA 510(k) clearance on 2024-09-27 under 510(k) number K241939. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the EasyCare Tx 2?

EasyCare Tx 2 is a medical device that received FDA 510(k) clearance on 2024-09-27. The listed applicant is Resmed Corp. The 510(k) number is K241939.

When did EasyCare Tx 2 receive FDA 510(k) clearance?

EasyCare Tx 2 received FDA 510(k) clearance on 2024-09-27, under 510(k) number K241939.

Who is the listed applicant for EasyCare Tx 2?

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

What is the FDA product code for EasyCare Tx 2?

The FDA product code for EasyCare Tx 2 is BZD.

Resmed Corp를 신청인으로 등재한 기타 기록

K261360EasyCare Tx 2 K253553Orion K254104ResScan Essentials K251889myAir K251657Personalized Therapy Comfort Settings (PTCS)K250624myAir

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