FDA 510(k)

RTMsense Respiratory Monitoring System

Número K: K243183 · 2025-06-27

Data da decisão2025-06-27

Código do produtoBZQ

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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