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FDA 510(k)

DynoSense Vital Sign Measuring System

K-Number: K190090 · 2019-08-02

ApplicantDynosense Corp.
Decision Date2019-08-02
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DynoSense Vital Sign Measuring System is the device name listed in this FDA 510(k) record. The listed applicant is Dynosense Corp.. It received FDA 510(k) clearance on 2019-08-02 under 510(k) number K190090. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DynoSense Vital Sign Measuring System?

DynoSense Vital Sign Measuring System is a medical device that received FDA 510(k) clearance on 2019-08-02. The listed applicant is Dynosense Corp.. The 510(k) number is K190090.

When did DynoSense Vital Sign Measuring System receive FDA 510(k) clearance?

DynoSense Vital Sign Measuring System received FDA 510(k) clearance on 2019-08-02, under 510(k) number K190090.

Who is the listed applicant for DynoSense Vital Sign Measuring System?

The FDA 510(k) record lists Dynosense Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DynoSense Vital Sign Measuring System?

The FDA product code for DynoSense Vital Sign Measuring System is MWI.

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.

NCT02907255Vital Sign Monitoring With Continuous Pulse Oximetry and Wireless Clinician Notification After SurgeryCOMPLETEDNCT06968845A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary FibrosisRECRUITINGNCT07105189Feasibility of Wireless Continuous Vital Sign Monitoring and Impact on Patients Undergoing Adult Spinal Surgery in a General WardRECRUITING

Related Devices (Code: MWI)

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.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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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