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FDA 510(k)

Patient Cables and Leadwires , Disposable ECG Leadwires

K-Number: K182327 · 2019-01-30

ApplicantOrantech, Inc.
Decision Date2019-01-30
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Patient Cables and Leadwires , Disposable ECG Leadwires is a medical device manufactured by Orantech, Inc.. It received FDA 510(k) clearance on 2019-01-30 under approval number K182327. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Patient Cables and Leadwires , Disposable ECG Leadwires?

Patient Cables and Leadwires , Disposable ECG Leadwires is a medical device that received FDA 510(k) clearance on 2019-01-30. It is manufactured by Orantech, Inc.. The 510(k) number is K182327.

When was Patient Cables and Leadwires , Disposable ECG Leadwires approved by the FDA?

Patient Cables and Leadwires , Disposable ECG Leadwires received FDA 510(k) clearance on 2019-01-30, under approval number K182327.

What company makes Patient Cables and Leadwires , Disposable ECG Leadwires?

Patient Cables and Leadwires , Disposable ECG Leadwires is manufactured by Orantech, Inc..

What is the FDA product code for Patient Cables and Leadwires , Disposable ECG Leadwires?

The FDA product code for Patient Cables and Leadwires , Disposable ECG Leadwires is DSA.

Related Clinical Trials

NCT06926881 OLE Therapy With BE Patients in Home Care Study RECRUITING

Other Devices by Orantech, Inc.

K173194Temperature Probe K181270Disposable SpO2 Sensors, Reusable SpO2 Sensors K173197Reusable NIBP Cuff K171828ETCO2 Sensor

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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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