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)

MobileECG 2 BT

K-Number: K181658 · 2019-03-26

ApplicantMemtec Corporation
Decision Date2019-03-26
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MobileECG 2 BT is a medical device manufactured by Memtec Corporation. It received FDA 510(k) clearance on 2019-03-26 under approval number K181658. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MobileECG 2 BT?

MobileECG 2 BT is a medical device that received FDA 510(k) clearance on 2019-03-26. It is manufactured by Memtec Corporation. The 510(k) number is K181658.

When was MobileECG 2 BT approved by the FDA?

MobileECG 2 BT received FDA 510(k) clearance on 2019-03-26, under approval number K181658.

What company makes MobileECG 2 BT?

MobileECG 2 BT is manufactured by Memtec Corporation.

What is the FDA product code for MobileECG 2 BT?

The FDA product code for MobileECG 2 BT is DSI.

Related Devices (Code: DSI)

K153473Braemar Telemetry Patch SystemBraemar Manufacturing, LLC K153477EMMa Electronic Monitoring ManagementVitasystems GmbH K152701Matrix Mini ECG MonitorGlobal Instrumentation, LLC K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation K151835Vital Signs Patch SystemLifewatch Technologies , Ltd. K151269ECG Mini System Continuous ECG Monitor and Arrhythmia DetectorLifewatch Technologies , Ltd.

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.

↑