FDA 510(k)

Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)

K-번호: K250093 · 2025-09-26

결정일2025-09-26

제품 코드BZQ

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

Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) is the device name listed in this FDA 510(k) record. The listed applicant is Linshom Medical, Inc.. It received FDA 510(k) clearance on 2025-09-26 under 510(k) number K250093. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)?

Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) is a medical device that received FDA 510(k) clearance on 2025-09-26. The listed applicant is Linshom Medical, Inc.. The 510(k) number is K250093.

When did Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) receive FDA 510(k) clearance?

Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) received FDA 510(k) clearance on 2025-09-26, under 510(k) number K250093.

Who is the listed applicant for Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)?

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

What is the FDA product code for Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)?

The FDA product code for Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) is BZQ.

Linshom Medical, Inc.를 신청인으로 등재한 기타 기록

K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)

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