Stethee Pro 1, Stethee Pro Software System
K-Number: K193631 · 2020-10-09
ApplicantM3Dicine Pty , Ltd.
Decision Date2020-10-09
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Stethee Pro 1, Stethee Pro Software System is a medical device manufactured by M3Dicine Pty , Ltd.. It received FDA 510(k) clearance on 2020-10-09 under approval number K193631. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Stethee Pro 1, Stethee Pro Software System?
Stethee Pro 1, Stethee Pro Software System is a medical device that received FDA 510(k) clearance on 2020-10-09. It is manufactured by M3Dicine Pty , Ltd.. The 510(k) number is K193631.
When was Stethee Pro 1, Stethee Pro Software System approved by the FDA?
Stethee Pro 1, Stethee Pro Software System received FDA 510(k) clearance on 2020-10-09, under approval number K193631.
What company makes Stethee Pro 1, Stethee Pro Software System?
Stethee Pro 1, Stethee Pro Software System is manufactured by M3Dicine Pty , Ltd..
What is the FDA product code for Stethee Pro 1, Stethee Pro Software System?
The FDA product code for Stethee Pro 1, Stethee Pro Software System is DQD.
Related Clinical Trials
NCT03331380
Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System
RECRUITING
NCT07608939
Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers
NOT_YET_RECRUITING
NCT03053141
RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY)
RECRUITING
NCT04910841
Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine
RECRUITING
NCT04662905
Novel Treatment Delivery of ECAP-controlled Closed-loop SCS for Chronic Pain
RECRUITING
NCT07557147
Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor
NOT_YET_RECRUITING
Related PubMed Literature
PMID: 42175114
Make Open Source Compliant: Validation in Non-Interventional Clinical Studies.
Studies in health technology and informatics (2026)
PMID: 40845310
Should Digital Interventions for HIV Self-Testing Be Regulated with World Health Organization Prequalification?
JMIR mHealth and uHealth (2025)
Other Devices by M3Dicine Pty , Ltd.
Related Devices (Code: DQD)
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.