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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 a medical device manufactured by Rtm Vital Signs, LLC. It received FDA 510(k) clearance on 2025-06-27 under approval 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. It is manufactured by Rtm Vital Signs, LLC. The 510(k) number is K243183.

When was RTMsense Respiratory Monitoring System approved by the FDA?

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

What company makes RTMsense Respiratory Monitoring System?

RTMsense Respiratory Monitoring System is manufactured by Rtm Vital Signs, LLC.

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

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

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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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