Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Strados Remote Electronic Stethoscope Platform (RESP)

K-Number: K220893 · 2022-04-27

ApplicantStrados Labs, Inc.
Decision Date2022-04-27
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Strados Remote Electronic Stethoscope Platform (RESP) is a medical device manufactured by Strados Labs, Inc.. It received FDA 510(k) clearance on 2022-04-27 under approval number K220893. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Strados Remote Electronic Stethoscope Platform (RESP)?

Strados Remote Electronic Stethoscope Platform (RESP) is a medical device that received FDA 510(k) clearance on 2022-04-27. It is manufactured by Strados Labs, Inc.. The 510(k) number is K220893.

When was Strados Remote Electronic Stethoscope Platform (RESP) approved by the FDA?

Strados Remote Electronic Stethoscope Platform (RESP) received FDA 510(k) clearance on 2022-04-27, under approval number K220893.

What company makes Strados Remote Electronic Stethoscope Platform (RESP)?

Strados Remote Electronic Stethoscope Platform (RESP) is manufactured by Strados Labs, Inc..

What is the FDA product code for Strados Remote Electronic Stethoscope Platform (RESP)?

The FDA product code for Strados Remote Electronic Stethoscope Platform (RESP) is DSH.

Related Clinical Trials

NCT07595289 DP-DCT 1.0：A Comparative Clinical Study on the Effect of Dapagliflozin Combined With CGM Versus SMBG on Glycemic Control in Patients With Type 2 Diabetes Mellitus Based on the DP-DCT Platform NOT_YET_RECRUITING NCT07590349 Personalized Robotic Telerehabilitation for Upper Limb Functional Recovery After Stroke in a Home-Based Setting NOT_YET_RECRUITING NCT03636230 Virtual E-health System for Pacemakers ACTIVE_NOT_RECRUITING NCT06969560 WeRoaM: Wearable Remote Monitoring in Heart Failure RECRUITING NCT06647576 Exploring Neurosphere's Remote Monitoring and Virtual Clinic Features in Improve Quality of Life and Reduce Costs COMPLETED NCT05116176 TRAjectories and CLinical ExpeRiences of ICD Therapy Study ENROLLING_BY_INVITATION

Related Devices (Code: DSH)

K162571Bioflux SoftwareBiotricity, Inc. K160704myPatch-sDms-Service, LLC K171936Peerbridge Cor(TM) SystemPeerbridge Health, Inc. K162503Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView SoftwareCardiac Insight, Inc. K163535my Patch slDms-Service, LLC K173461ECG recorder and Arrhythmia DetectorSmart Solutions Technologies SL

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.

↑