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FDA 510(k)

Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)

K-Number: K250093 · 2025-09-26

ApplicantLinshom Medical, Inc.
Decision Date2025-09-26
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Linshom Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)

Related Devices (Code: BZQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253274BedDot (G1)Intelligent Dots, LLCK251326Respiration Rate algorithmEdwards Lifesciences, LLCK250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLCK243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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