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FDA 510(k)

RTMsense Respiratory Monitoring System

K-Number: K243183 · 2025-06-27

ApplicantRtm Vital Signs, LLC
Decision Date2025-06-27
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RTMsense Respiratory Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Rtm Vital Signs, LLC. It received FDA 510(k) clearance on 2025-06-27 under 510(k) number K243183. 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 RTMsense Respiratory Monitoring System?

RTMsense Respiratory Monitoring System is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Rtm Vital Signs, LLC. The 510(k) number is K243183.

When did RTMsense Respiratory Monitoring System receive FDA 510(k) clearance?

RTMsense Respiratory Monitoring System received FDA 510(k) clearance on 2025-06-27, under 510(k) number K243183.

Who is the listed applicant for RTMsense Respiratory Monitoring System?

The FDA 510(k) record lists Rtm Vital Signs, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RTMsense Respiratory Monitoring System?

The FDA product code for RTMsense Respiratory Monitoring System is BZQ.

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, LLCK250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.K243966FaceHeart 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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