FDA 510(k)

Optiflow 스위치+ CO2 채집을 위한 필터된 코널 인터페이스 (AA042J)

K-번호: K253479 · 2025-12-19

결정일2025-12-19

제품 코드BTT

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

Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K253479. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)?

Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K253479.

When did Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) receive FDA 510(k) clearance?

Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) received FDA 510(k) clearance on 2025-12-19, under 510(k) number K253479.

Who is the listed applicant for Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)?

The FDA 510(k) record lists Fisher & Paykel Healthcare, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)?

The FDA product code for Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) is BTT.

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