K Number
K961364Device Name
AUTOMATIC TUBING CLAMP SYSTEM (ATC)Manufacturer
Date Cleared
1996-10-31
(205 days)
Product Code
Regulation Number
870.4205Type
TraditionalPanel
CVReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 870.4205 Cardiopulmonary bypass bubble detector.
(a)
Identification. A cardiopulmonary bypass bubble detector is a device used to detect bubbles in the arterial return line of the cardiopulmonary bypass circuit.(b)
Classification. Class II (performance standards).