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510(k) Data Aggregation
K Number
K182220Device Name
Curbell branded Patient Monitoring Cables
Manufacturer
Curbell Medical Products, Inc.
Date Cleared
2018-11-07
(84 days)
Product Code
DSA
Regulation Number
870.2900Why did this record match?
Applicant Name (Manufacturer) :
Curbell Medical Products, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Curbell patient cables are used to connect electrodes and/or sensors placed at the appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by a healthcare professional.
Device Description
Curbell Patient Monitoring Cables comprise cables and lead wires that connect from sensors and/or electrodes to a monitor for the purpose of conducting ECG diagnosis, monitoring, and SPO2 monitoring. As per 21CFR801.109, this device is a prescription device.
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